Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- QODExtracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary FailureNProduct Code
- QRJLaser-Powered Inferior Vena Cava Filter Retrieval Catheter2Product Code
- KPKMarker, Ostia, Aorto-Saphenous Vein2Product Code
- DSQVentricular (Assist) Bypass3Product Code
- FZCProsthesis, Arterial Graft, Bovine Carotid Artery3Product Code
- LOTPulse-Generator, Program Module3Product Code
- LOZArtificial Heart3Product Code
- LPASystem, Esophageal Pacing3Product Code
- LPBCardiac Ablation Percutaneous Catheter3Product Code
- LPCDevice, Angioplasty, Laser, Coronary3Product Code
- LWOPulse-Generator, Single Chamber, Sensor Driven, Implantable3Product Code
- LWPImplantable Pulse Generator, Pacemaker (Non-Crt)3Product Code
- LWQHeart-Valve, Mechanical3Product Code
- LWRHeart-Valve, Non-Allograft Tissue3Product Code
- LWSImplantable Cardioverter Defibrillator (Non-Crt)3Product Code
- P220012Aurora EV-ICD SystemAPPRPMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMAPPRPMA Approval
- P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOFAPPRPMA Approval
- P980023PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMAPPRPMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORSAPPRPMA Approval
- P970024ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM.APPRPMA Approval
- P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEMAPPRPMA Approval
- P940024GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.APPRPMA Approval
- P950022TVL(TM) LEAD SYSTEMAPPRPMA Approval
- P940008RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMSAPWDPMA Approval
- P110042EMBLEM subcutaneous implantable cardioverter defibrillation (S-ICD) Programmer, EMBLEM Pulse Generator (PG)3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P900061ACE Header End Cap, Epicardial Patch Lead, Upsizing Sleeve3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P950022Optisure™3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, E3PMA Approval
- P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA3PMA Approval
- P110042Subcutaneous ICD Devices3PMA Approval
- P910077LATITUDE Programming System3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P110042EMBLEM S-ICD pulse generator (PG) Models A209/A2193PMA Approval
- P900061Epicardial Patch Lead3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD3PMA Approval
- P980023PHYLAX AV ICD SYSTEM3PMA Approval
- P960040ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN™ MINI ICD VR,DYNAGEN MINI ICD D3PMA Approval
- P110042EMBLEM™ S-ICD; EMBLEM MRI S ICD3PMA Approval
- P110042EMBLEM S-ICD PG models A209 and A219.3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P960040Resonate family of CRT-D's3PMA Approval
- P960040Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, Origen Implantable Cardioverter Defibrillators3PMA Approval
- P110042Subcutaneous Implantable Defibrillator (S-ICD) System3PMA Approval
- P910073Endoktak Lead System3PMA Approval
- P830060Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems3PMA Approval
- P910073Endotak Lead System3PMA Approval
- P910073REL S, REL, REL SEZ, REL EZ DUAL COIL, REL SG, REL G, SEN3PMA Approval
- P960040ORIGEN VR, ORIGEN DR, INOGEN DR, INOGEN VR, DYNAGEN VR, DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL3PMA Approval
- P110042S-ICD GEN 2, S-ICD EMBLEM, EMBLEM S-ICD ELECTRODE3PMA Approval
- P980016Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Crome MRI ICD3PMA Approval
- P910073ENDOTAK Lead System3PMA Approval
- P110042S-ICD, Q-TRAK Subcutaneous Electrode, Q-TECH Programmer and Related Accessories3PMA Approval
- P980016Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD,Crome MRI ICD, Evera MRI DF-1 ICD, E3PMA Approval
- P960040ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN3PMA Approval
- P110042EMBLEM S-ICD3PMA Approval
- P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA3PMA Approval
- P910077LATITUDE™ NXT Remote Patient Management System, LATITUDE™Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NX3PMA Approval
- P910023Ellipse VR DR, Fortify Assura VR DR3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs3PMA Approval
- P980016Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI, Cobalt XT MRI, Crome MRI ICD, Crome MRI ICD,Evera MRI DF-1,Evera MRI DF-13PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev3PMA Approval
- P910023Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR3PMA Approval
- P980023Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-3PMA Approval
- P900061End Cap, Epicardial Patch Lead, Upsizing Sleeve3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD,3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Ev3PMA Approval
- P950022Durata, Optisure3PMA Approval
- P950022Durata, Optisure3PMA Approval
- P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM3PMA Approval
- P980023Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD3PMA Approval
- P910023Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Entrant, Gallant, Ellipse (MR Conditional)3PMA Approval
- P950022Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional)3PMA Approval
- P980016Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Pri3PMA Approval
- P980016Cobalt XT DR ICD MRI SureScan, Cobalt DR ICD MRI SureScan, Crome DR ICD MRI SureScan, Cobalt XT VR ICD MRI SureScan, Cob3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P110042EMBLEM S-ICD Lead3PMA Approval
- P910073RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P980016CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P830060VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS3PMA Approval
- P910073ENDOTAK LEAD SYSTEM3PMA Approval
- P910077VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR3PMA Approval
- P930035VENTAK(R) P2 SYSTEM3PMA Approval
- P960040ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD,3PMA Approval
- P960040ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR3PMA Approval
- P110042SICD Gen 2, SICD MRI3PMA Approval
- P980023PSW 2100.U and NEO 2100.U3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI D3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I3PMA Approval
- P910023Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional)3PMA Approval
- P950022Durata, Durata (MR Conditional), Optisure and Optisure (MR Conditional)3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD3PMA Approval
- P110042EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)3PMA Approval
- P910073ENDOTAK Lead System3PMA Approval
- P930035VENTAK P2 System3PMA Approval
- P110042S-ICD, Q-TRAK Subcutaneous Electrode, Q-Tech Programmer and Related Accessories3PMA Approval
- P960040VENTAK AV & VENTAK PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD, ORIGEN ICD, INOGEN I3PMA Approval
- P890061VENTAK P3PMA Approval
- P830060VENTAK3PMA Approval
- P910077VENTAK PRx and VENTAK MINI3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD and Crombe MRI ICD3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD3PMA Approval
- P980016Cobalt MRI ICD, CObalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/SR ICD, Evera XT DR/VR I3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P900061Epicardial Patch Lead3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M3PMA Approval
- P980016Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D3PMA Approval
- P910077LATITUDE Programming System3PMA Approval
- P110042Subcutaneous Implantable Defibrillator(S-ICD) System3PMA Approval
- P960040Ventak AV AICD, Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator Syste3PMA Approval
- P910073Endotak Lead System3PMA Approval
- P110042EMBLEM™ S-ICD Subcutaneous Electrode3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev3PMA Approval
- P980023Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-3PMA Approval
- P980016Protecta ICD, Protecta VR ICD, and Protecta XT ICD3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P950022Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional)3PMA Approval
- P910023Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional), Avant VR, Avant D3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I3PMA Approval
- P980050Transvene CS/SVS Lead3PMA Approval
- P900061ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P960040Ventak AV AICD Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste3PMA Approval
- P110042Subcutaneous Implantable Defibrillator (S-ICD) System3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P900061End Cap, Epicardial Patch Lead, and Upsizing Sleeve3PMA Approval
- P910073ENDOTAK LEAD SYSTEM3PMA Approval
- P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM3PMA Approval
- P980023Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, and Intica Neo 53PMA Approval
- P110042EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD3PMA Approval
- P900061Epicardial Patch Lead3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera3PMA Approval
- P110042EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator3PMA Approval
- P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD3PMA Approval
- P960040ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM3PMA Approval
- P110042S-ICD GEN 2 and S-ICD EMBLEM MRI3PMA Approval
- P980023Home Monitoring System Version 3.483PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M3PMA Approval
- P910023Fortify, Fortify Assura, and Ellipse3PMA Approval
- P910023Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional)3PMA Approval
- P950022Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional)3PMA Approval
- P960040ICD AUTOGEN DR, ICD AUTOGEN VR, ICD DYNAGEN DR, ICD DYNAGEN VR, ICD INOGEN DR, ICD INOGEN VR, ICD ORIGEN DR, ICD ORIGEN3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA - ICD Device3PMA Approval
- P110042EMBLEM S-ICD - Subcutaneous Devices3PMA Approval
- P910077LATITUDE™ NXT Patient Management System, LATITUDE™ Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NXT Syst3PMA Approval
- P110042EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator3PMA Approval
- P950022Durata, Optisure3PMA Approval
- P110042S-ICD GEN 2, S-ICD EMBLEM MRI3PMA Approval
- P960040ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD ORIGEN VR, ICD ORIGEN DR3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P980016Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, M3PMA Approval
- P910023Avant VR ICD, Avant DR ICD, Neutrino NxT VR ICD, Neutrino NxT DR ICD, Gallant VR ICD, Gallant DR ICD, Entrant VR ICD and3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+, Avant, Gallant, Entrant, Ne3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P910077LATITUDE Programming System (Programmer)3PMA Approval
- P110042EMBLEM S-ICD Programmer3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD3PMA Approval
- P910023Avanta, Neutrino NXT, Gallant, Entrant VR ICD and Avant, Neutrino, Gallant and Entrant DR ICD3PMA Approval
- P110042Subcutaneous Implantable Cardioverter Defibrillator3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P910023Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT3PMA Approval
- P900061Epicardial Patch Lead3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P110042EMBLEM S-ICD Pulse Generator3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P960040ORIGEN, INOGEN, DYNAGEN MINI ICD VR/DR, ORIGEN, MOMENTUM, INOGEN, DYNAGEN, VIGILANT, RESONATE EL ICD VR/DR, ICD AUTOGEN,3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve3PMA Approval
- P900061ACE Header, End Cap, Epicardial Patch Lead, Upsizing Sleeve3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P110042EMBLEM Subcutaneous Implantable Cardioverter Defibrillator S-ICD3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P980016Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD3PMA Approval
- P910073RELIANCE 4-FRONT3PMA Approval
- P910077LATITUDE Programming System3PMA Approval
- P110042EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System3PMA Approval
- P950022Durata And Optisure HV Passive Steroid Eluting Cardiac Leads3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs3PMA Approval
- P950022Durata and Optisure High Voltage Leads3PMA Approval
- P960040(ICD Devices) TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIV3PMA Approval
- P910077LATITUDE Programming System, Altrua/Insignia I/Nexus I3PMA Approval
- P910077LATITUDE Wave Communicators3PMA Approval
- P980016Cobalt MRI ICD,Cobalt XT MRI ICD,Crome MRI ICD,Evera MRI DF-1 ICD,Evera MRI ICD,Evera S DR ICD,Evera S VR ICD,Evera XT D3PMA Approval
- P950022Durata HV Leads3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P900061Epicardial Patch Lead3PMA Approval
- P980023PSW 1904.U3PMA Approval
- P110042EMBLEM Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD)3PMA Approval
- P980016Cobalt XT DR MRI SureScan, Cobalt DR MRI SureScan, Crome DR MRI SureScan, Cobalt XT VR MRI SureScan, Cobalt VR MRI SureS3PMA Approval
- P980023Drug-Eluting Permanent Defibrillator Electrodes3PMA Approval
- P910023Fortify, Fortify Assura, and Ellipse3PMA Approval
- P950022Durata and Optisure High Voltage Lead3PMA Approval
- P950022Optisure High Voltage Leads3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M3PMA Approval
- P980023Implantable Cardioverter Defibrillator (Non-CRT)3PMA Approval
- P980016Visia AF MRI DF1 ICD, Visia AF MRI VR ICD, and Visia AF VR ICD3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P980016Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia3PMA Approval
- P980016Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DD3PMA Approval
- P980023Implantable Cardioverter Defibrillator (Non-CRT)3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot3PMA Approval
- P960040ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN3PMA Approval
- P110042S-ICD GEN 2 and S-ICD EMBLEM MRI3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI3PMA Approval
- P110042Subcutaneous ICD Devices: EMBLEM S-ICD3PMA Approval
- P960040ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC3PMA Approval
- P910077LATITUDE NXT System - LATITUDE NXT Patient Management System, LATITUDE Wave Communicator and LATITUDE NXT System Server3PMA Approval
- P950022Durata, Optisure3PMA Approval
- P110042EMBLEM S-ICD System3PMA Approval
- P960040ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR3PMA Approval
- P110042SICD Gen 2 and SICD MRI3PMA Approval
- P910023Ellipse DR and Ellipse VR3PMA Approval
- P900061ACE Header, Epicardial Patch Lead3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P960040ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN3PMA Approval
- P110042S-ICD GEN and S-ICD EMBLEM MRI3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera VR ICD, Intrinsic 30 ICD, Marq3PMA Approval
- P910023Fortify, Fortify Assura, and Ellipse3PMA Approval
- P950022Durata and Optisure3PMA Approval
- P980023Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode, Stylet Catheter3PMA Approval
- P960040ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Protecta3PMA Approval
- P910023Current+, Fortify, Fortify Assura, Ellipse3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs3PMA Approval
- P110042Emblem Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)3PMA Approval
- P110042EMBLEM S-ICD Automated Screening Tool3PMA Approval
- P910077Multiple Application Utility (MAU) and Data Management System (DM) LATITUDE Programming System )LPS)3PMA Approval
- P980016Evera S DR/VR ICd, Evera XT DR/VR ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR/VR ICD, and Primo MRI DR/VR ICD3PMA Approval
- P980050Transvene CS-SVC Lead3PMA Approval
- P980016Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Mirro MRI DR, Mirro MRI VR, Primo MRI DR, P3PMA Approval
- P960040Origen Mini ICD VR, Origen Mini ICD DR, Inogen Mini ICD VR, Inogen Mini ICD DR, Dynagen Mini ICD VR, Dynagen Mini ICD DR3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P900061Epicardial Patch Lead3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S VR/DR/ICD, Evera XT DR/VR/ ICD, Mirror MRI DR/VR ICD, Primo MRI DR/VR ICD, Pr3PMA Approval
- P910077LATITUDE Programming System3PMA Approval
- P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM3PMA Approval
- P910023Ellipse ICD Devices3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot3PMA Approval
- P110042Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)3PMA Approval
- P960040Implantable Cardioverter Defibrillator (ICD)3PMA Approval
- P950022Durata and Optisure HV Active Steroid Eluting Cardiac Leads3PMA Approval
- P910023Ellipse hybrid3PMA Approval
- P980023Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode and Styley Catheter3PMA Approval
- P960040ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC3PMA Approval
- P910077LATITUDE Programming System, Brady v1.06 with Heart Connect3PMA Approval
- P910023Ellipse, Fortify, Fortify Assura and Quadra Assura MP ICD3PMA Approval
- P110042EMBLEM S-ICD Electrode3PMA Approval
- P980016Evera MRI DF1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR3PMA Approval
- P980023PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM3PMA Approval
- P980016Evera/Visia AF MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR3PMA Approval
- P900061Ace Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve3PMA Approval
- P960040Origen, Inogen, Dynagen, Autogen, Vigilant, Resonate, Perciva, and Momentum Implantable Cardioverter Defibrillator (ICD)3PMA Approval
- P960040Autogen, Dynagen, Inogen, and Origen NG3 ICDs and Resonate, Momentum, Vigilant, and Perciva NG4 ICDs3PMA Approval
- P110042Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) pulse generator (PG) high voltage (HV) capacitor stack3PMA Approval
- P980016Evera MRI DF-1, MRI, S DR, S VR, XT DR, XT VR, Mirro MRI DR, MRI VR, Primo MRI DR, MRI VR, Visia AF MRI DF1, AF MRI VR,3PMA Approval
- P910023Ellipse, Fortify, Fortify Assura, and Quadra Assura MP ICD Devices3PMA Approval
- P980023Ilivia Neo 7 VR-T, Intica Neo 7 and 5 VR-T, Ilivia Neo 7 VR-T DX, and Intica Neo 7 and 5 VR-T DX3PMA Approval
- P980016Protecta ICD, Protecta VR, XT ICD and Secura ICD, Secura DR ICD3PMA Approval
- P910023Fortify and Fortify Assura ICD Devices3PMA Approval
- P980016Evera MRI DF-1, Evera S DR/VR, Evera XT DR/VR, Mirro MRI DR/VR, Primo MRI DR/VR, Protecta VR/XT, Secura DR, Visia AF MRI3PMA Approval
- P980016Evera RI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mi3PMA Approval
- P910073Reliance 4-Front Leads, Suture Sleeve Accessory for Reliance 4-Front Leads, Endotak Reliance 4-Site Leads and Endotak Re3PMA Approval
- P960040Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, and Origen Implantable Cardioverter Defibrillators (ICD3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P980016Evera, S, XT, DR, VR, Mirro, Primo MRI, DR, VR; Protecta VR, XT; Secura; Visia AF, MRI, VR ICD3PMA Approval
- P980016Evera MRI DF-1, MRI, S DR, S VR, XT DR, and XT VR ICD, Mirro MRI DR and MRI VR ICD, Primo MRI DR and MRI VR ICD, Protect3PMA Approval
- P110042EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD,3PMA Approval
- P910077LATITUDE Programming System3PMA Approval
- P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERCIVA ICD Devic3PMA Approval
- P960040ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC3PMA Approval
- P910077LATITUDE Programming System3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P900061Epicardial Patch Lead3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI VR/DR ICD, Prot3PMA Approval
- P960040NG3 and NG4 Implantable Cardioverter Defibrillators (ICDs)3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P910073RELIANCE 4-FRONT Steroid Eluting Leads3PMA Approval
- P980016Evera MRI, Evera, Marquis, Secura Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, Visia AF3PMA Approval
- P960040ICD Devices TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA3PMA Approval
- P110042Subcutaneous ICD Devices: EMBLEM3PMA Approval
- P910077LATITUDE Wave Communicator3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro/Primo MRI DR/VR ICD, Protecta ICD, Prote3PMA Approval
- P980016Evera MRI XT DR/VR SureScan, Evera MRI S DR/VR SureScan and Visia AF MRI VR SureScan and Implantable Cardioverter Defibr3PMA Approval
- P910023Torque Wrench/Torque Driver3PMA Approval
- P980023Phylax ICD System3PMA Approval
- P110042EMBLEM Programmer3PMA Approval
- P900061Epicardial Patch Lead3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Protecta ICD, Pro3PMA Approval
- P980016Ever MRI DF-1 ICD, Ever MRI ICD, Ever S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Visia A3PMA Approval
- P980016Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Mirro MRI DR, Mirro MRI VR, Primo MRI DR, P3PMA Approval
- P980023Plexa ProMRI DF- S DX 65/15/17; IIivia 7 DR-T; Inrica 5 DTR-T3PMA Approval
- P980016Evera, Mirro, Primo, Protecta, Secura, Visia, S DR, VR XT DF1 MRI ICD3PMA Approval
- P980023Protego TD, SD 75/18, 65/18, 65/16 and SD 60/16 Protego T 65, and S 75, 65, 60 Plexa S 60, PLexa SD 60/16, Plexa ProMRI3PMA Approval
- P980023Permanent Defibrillator Electrodes: Protego SD, Protego TD, Protego S and Protego T3PMA Approval
- P830060Accessory Medical Adhesive, Accessory Mineral Oil, Accessory Vein Pick, Accessory Kit Lead Cap, Accessory Stylet TAPER 03PMA Approval
- P930035Accessory Wrench3PMA Approval
- P910073LV Lead Quadpole Connector IS4, Accessory Kit Lead Cap, Accessory Stylet TAPER FIX SOFT 64CM, 70CM, and 100CM, Accessory3PMA Approval
- P110042Emblem S-ICD Electrode 45cm3PMA Approval
- P910077ZOOM LATTITUDE Programmer System Accessory Kit, Adapter Power RF COmmunicator, Accessory Kit Lead Cap, Accessory Wand T3PMA Approval
- P110042Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) plus generator (PG) devices3PMA Approval
- P900061ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve3PMA Approval
- P980050Transvene CS/SVS Lead3PMA Approval
- P980016Evera: MRI DF-1 ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, MRI VR ICD; Primo MRI DR ICD,3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD; Mirro MRI DR ICD, M3PMA Approval
- P960040Implantable Cardioverter Defibrillator3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs3PMA Approval
- P980016Secura DR ICD, Maximo II DR ICD, Protecta XT DR ICD, Protecta DR ICD, Secura VR ICD, Maximo II VR ICD, Protecta XT VR IC3PMA Approval
- P910073Reliance 4-Front, 4-Site IS-1 Defibrillation3PMA Approval
- P110042Emblem S-ICD, Electrode3PMA Approval
- P910077LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator and LATITUDE NXT Syste3PMA Approval
- P110042EMBLEM (Subcutaneous ICD Devices)3PMA Approval
- P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, and PERCIVA (ICD Dev3PMA Approval
- P980023Plexa ProMRI S DX ICD Leads3PMA Approval
- P960040NG3 Devices3PMA Approval
- P980023Protego SD/TD; Protego DF-1 SD; Protego ProMRI SDX; Protego DF-1 ProMRI SD; Plexa SD; Plexa ProMRI SD; Plexa DF-1 SD; Pl3PMA Approval
- P960040Implantable Cardioverter Defibrillator (ICD) Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate and Perciva3PMA Approval
- P110042Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM S-ICD/MRI S-ICD3PMA Approval
- P910073Reliance 4-Front Lead Family (passive fixation models)3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P910077Programmer Recorder Monitor (PRM) for Implantable Pulse Generators, Model 3300 LATITUDE Programming System, Model 6395 I3PMA Approval
- P950022Durata, Optisure High Voltage Passive, High Voltage Active3PMA Approval
- P980023Implantable Cardioverter Defibrillatory (Non-CRT) and Defibrillatort, Implantable, Dual-Chamber3PMA Approval
- P910023Tendril STS 2088TC Lead3PMA Approval
- P910023Cortify, Fortify Assura, and Ellipse3PMA Approval
- P950022Durata and Optisure3PMA Approval
- P110042EMBLEM S-ICD Pulse Generator; EMBLEM MRI S-ICD Pulse Generator3PMA Approval
- P950022Durata, Optisure High Voltage Active and Passive Leads3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Protecta ICD, Protecta VR/XT ICD, Secura DR IC3PMA Approval
- P110042EMBLEM S-ICD PG Models A209 and A2193PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot3PMA Approval
- P900061Epicardial Patch Lead3PMA Approval
- P980016Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR, VR ICD; Evera XT DR, VR ICD; Mirro MRI DR , VR ICD; Primo MRI DR, VR ICD;3PMA Approval
- P960040PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE3PMA Approval
- P110042EMBLEM, EMBLEM MRI3PMA Approval
- P980016Evera MRI ICD,S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD,VR ICD: Visia AF MRI3PMA Approval
- P910073ENDOTAK RELIANCE 4-SITE Leads3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Mirro MRI DR ICD, Mirro VR ICD, Prim3PMA Approval
- P900061ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P950022Durata, Optisure,3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Visi3PMA Approval
- P910023Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional)3PMA Approval
- P980016Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Mirro MRI DR ICD; M3PMA Approval
- P950022Durata and Optisure High Voltage Leads3PMA Approval
- P980016Evera MRI, ICD, DF-1 ICD, S DR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD, VR ICD; Visia AF M3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P910023Fortify, Fortify Assura, Ellipse3PMA Approval
- P950022Durata, Optisure3PMA Approval
- P110042Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Electrode3PMA Approval
- P980016Evera MRI DF-1 ICD,Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mi3PMA Approval
- P980016Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, VIsia AF, Primo DR and VR M3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P960040ICDs Autogen, Inogen, Dynagen, Origen, Resonate, Momentum, Vigilant, Perciva, Punctua, Energen, and Incepta3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICVD, Primo MRI VR ID, Visia AF MRI3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD3PMA Approval
- P950022HV Steroid Eluting Cardiac Leads3PMA Approval
- P110042EMBLEM S-ICD & EMBLEM MRI S-ICD3PMA Approval
- P980016Protecta ICD, Protecta VR ICD, and Protecta XT ICD3PMA Approval
- P980016Evera MRI: DF-1 ICD, ICD; Evera S: DR ICD, VR ICD; Evera XT, DR ICD, VR ICD; Mirro MRI: DR ICD, VR ICD; Primo MRI: DR IC3PMA Approval
- P110042Emblem S-ICD, Emblem MRI S-ICD3PMA Approval
- P960040Dynagen Mini ICD, Inogen Mini/EL ICD, Origen Mini/EL ICD, Dynagen EL ICD, Autogen EL ICD, Vigilant EL ICD, Perciva ICD,3PMA Approval
- P960040MANAGE HF Study3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P910023Current+; Fortify; Fortify Assura; Fortify Assura (MR Conditional); Ellipse; Ellipse (MR Conditional)3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P980016Protecta ICD, Protecta VR/XT ICD3PMA Approval
- P980023Protego SD; Protego TD; Protego DF-1 SD; Protego ProMRI SDx; Protego DF-1; ProMRI SD; Plexa SD; Plexa ProMRI SD; Plexa D3PMA Approval
- P910073Endotak Reliance, Reliance 4-Front3PMA Approval
- P110042Emblem S-ICD Electrode3PMA Approval
- P980016Evera MRI DF-I ICD / Evera MRI ICD/ S DR ICD / S VR ICD / XT DR ICD /XT VR ICD ; Mirro MRI DR ICD / MRI VR ICD; Primo MR3PMA Approval
- P950022Durata and Optisure3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/ S VR ICD, Evera XT DR/ XT VR ICD, Primo MRI DR/VR ICD, Visia AF MRI DF1 I3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P960040DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016Evera MRIS XT DR/XT VR/S DR/S VR SureScan, Visia AF MRI XT and S VR SureScan, Primo MRI SureScan and Mirro MRI SureScan3PMA Approval
- P950022Durata and Optisure Leads3PMA Approval
- P110042EMBLEM S-ICD Pulse Generator (PG), EMBLEM MRI S-ICD Pulse Generator (PG)3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P910023Ellipse, Fortify, Fortify Assura and Quadra Assura MP3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR/VR IC3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P900061ACE Header, Defibrillation Support Device (DISD), End Cap, Epicardial Patch Lead, Upsizing Sleeve3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot3PMA Approval
- P980016Evera MRI DF-1, Evera MRI ICD's; Mirro MIR DR, Mirro MIR VR ICD's; Primo MRI DR, Primo MRI VR ICD's; Visia AF MRI DF1, V3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF2 IC3PMA Approval
- P960040Implantable Cardioverter Defibrillator (ICD), Dynagen EL/Mini ICD, Inogen EL/Mini ICD, Origen EL ICD/Mini ICD, Autogen E3PMA Approval
- P110042S-ICD Pulse Generator, Emblem S-ICD, Emblem MRI S-ICD3PMA Approval
- P980016Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II and Visia AF3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P910073Endotak Reliance IS-1 Lead Family, Endotak Reliance IS4 Lead Family, Reliance 4-Front Lead Family3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XR DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P110042EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG)3PMA Approval
- P110042S-ICD Battery Anode Laser Edge Weld Process3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD< Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P910073Reliance 4- Front Lead Family and Suture Sleeve Accessory3PMA Approval
- P980016Evera NRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD,3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD,3PMA Approval
- P910023Ellipse VR, Ellipse DR, Fortify, Fortify Assura3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P110042Subcutaneous Implantable Defibrillator (S-ICD) System3PMA Approval
- P930035Ventak(R) P2 System3PMA Approval
- P830060Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems3PMA Approval
- P960040Ventak AV Acid Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste3PMA Approval
- P910073Endotak Lead System3PMA Approval
- P910077Ventak(R) PRX (TM) Model 1700,1705 Pulse Generator3PMA Approval
- P980016Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maxim3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P910073Lead Cap Kit (model 7007)3PMA Approval
- P110042Emblem S-ICD Electrode Delivery System (model 4712)3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+family of ICDS3PMA Approval
- P960040NG2.5 (Dynagen Mini/Inogen Mini/ Origen Mini), Pervica ICD Pulse Generator3PMA Approval
- P980016Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR/VR ICD; Evera XT DR/VR ICD; Mirro MRI DR/VR ICD; Primo MRI DR/VR ICD; Visi3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M3PMA Approval
- P910023Fortify Models CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Assura Models CD1257-40, CD1257-40Q, CD2257-40, CD23PMA Approval
- P910023Forify, Fortify Assura3PMA Approval
- P980016Protecta ICD, Protecta VR ICD, ProtectaXT ICD, Secura DR ICD, Secura ICD3PMA Approval
- P950022Durata and Optisure Leads (HV Active and Passive)3PMA Approval
- P110042Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM MRI S-ICD and S-ICD Pulse Generator3PMA Approval
- P980016Primo MRI DR/VR SureScan; Mirro MRI DR/VR SureScan3PMA Approval
- P950022Durata and Optisre Family of High Voltage Leads3PMA Approval
- P960040Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Perciva3PMA Approval
- P910077Latitude Programming System3PMA Approval
- P960040RESONATE, MOMENTUM, VIGILANT, and PERCIVA NG4 ICDs3PMA Approval
- P950022Durata, Optisure3PMA Approval
- P950022Durata, Optisure3PMA Approval
- P900061End Cap and Upsizing Sleeve3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P110042Subcutaneous ICD Device (S-ICD): EMBLEM, EMBLEM MRI3PMA Approval
- P960040Implantable Cardioverter Defibrillator (ICD): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIG3PMA Approval
- P910023Current, Fortify, Fortify Assura, Ellipse3PMA Approval
- P910023Ellipse3PMA Approval
- P980016Primo MRITM SureScan TM & Mirro MRITM SureScan TM3PMA Approval
- P950022Durata, Optisure3PMA Approval
- P910023Current+, Fortify, Fortify Assura, Ellipse3PMA Approval
- P960040NG3 Implantable Cardioverter Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 - Momentum, Vigilant, Resonate, Per3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DDR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Protecta ICD, Prot3PMA Approval
- P980023Protego SD/TD/S/T; Protego DF-1 SD/DF-1S; Protego ProMRI SDX/DF-1 ProMRI SDX; Protego DF-1 ProMRI SD/DF-1 ProMRI S; Plex3PMA Approval
- P980023Phylax Implantable Cardioverter Defibrillator System3PMA Approval
- P950022Durata and Optisure High Voltage Leads3PMA Approval
- P960040DYNAGEN EL/MINI; INOGEN EL/MINI; ORIGEN EL/MINI; AUTOGEN EL; VIGILIANT EL; PERCIVA; RESONATE EL/HF; PERCIVA HF; MOMENTUM3PMA Approval
- P110042EMBLEM S-ICD; EMBLEM MRI S-ICD3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC3PMA Approval
- P910023Fortify Assura3PMA Approval
- P910077Ventak PRx and Ventak Mini AICDs3PMA Approval
- P960040NG3 Family of ICDs (Autogen, Dynagen, Inogen and Origen) NG4 Family of ICDs (Resonate, Vigilant and Perciva)3PMA Approval
- P910023Current+, Ellipse, Fortify, Fortify Assura, and Quadra Assura MP3PMA Approval
- P980016Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, and Evera XT VR ICD3PMA Approval
- P960040Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate, Perciva,Punctua, Energen, Incepta ICD3PMA Approval
- P110042Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)3PMA Approval
- P960040Implantable Cardioverter Defibrillator / Momentur, Vigilant, Resonate, Perciva3PMA Approval
- P110042Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)3PMA Approval
- P110042EMBLEM MRI S-ICD; EMBLEM S-ICD3PMA Approval
- P960040DYNAGEN, INOGEN, ORIGEN, AUTOGEN EL ICD; DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD; INCEPTA, ENERGEN, PUNCTUA ICD; MOME3PMA Approval
- P910077Latitude Programming System3PMA Approval
- P960040Ventak AV Aicd Ventak Prizm DR/VR, Vitality, Cofient and Teligen Automatic Implantable Cardiovetr Defibrillator System3PMA Approval
- P910023Lead Cap (IS-1/DF-1/SJ4/DF/IS4) IS4/DF4 Port Plug; DF-1 Receptacle Plug; IS-1 Receptacle Plug3PMA Approval
- P950022IS4/DF4 Connector Sleeve; Suture Sleeve; Suture Sleeve Kit3PMA Approval
- P910073ENDOTAK RELIANCE S /GS /G3PMA Approval
- P980016Evera MRI ICD / Evera S DR / S VR /XT DR / XT VR ICD; Visia AF MRI VR ICD / Visia AF VR ICD3PMA Approval
- P980016Evera MRI DF-1 ICD / Evera S DR /VR ICD / Evera XT VR ICD / Protecta ICD / Protecta XT ICD /Visia AF MRI DF 1 ICD / Visi3PMA Approval
- P960040Autogen, Dynagen, Energen, Incepta, Inogen, Momentum, Origen, Perciva, Punctua, Resonate, Vigiliant, Vitality ICDs3PMA Approval
- P110042Emblem, Emblem MRI S-ICDs3PMA Approval
- P980023Linox Smart, Protego, and Plexa3PMA Approval
- P950022Cardiac Resynchronization Therapy Defibrillator (CRT-D)3PMA Approval
- P910023Implantable Cardioverter Defibrillator (ICD)3PMA Approval
- P980016Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI VR ICD, Visia AF VR ICD3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Protecta ICD, Prote3PMA Approval
- P900061Epicardial Patch Lead3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016Evera MRI ICD,Evera S DR ICD,Evera MRI DF-1 ICD,Evera S VR ICD,Evera XT DR ICD, Evera XT VR ICD,Protecta ICD, Protecta V3PMA Approval
- P960040Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Pervica3PMA Approval
- P110042Emblem3PMA Approval
- P910077Latitude NXT Patient Management System, Wave Communicator, G2 Communicator, Consult Communicator, NXT System Server Soft3PMA Approval
- P980016Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Visia AF MRI DF1 IC3PMA Approval
- P960040NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Protecta ICD, Prote3PMA Approval
- P910023Fortify; Fortify Assura3PMA Approval
- P910023Fortify Assura , Ellipse3PMA Approval
- P960040ORIGEN / INOGEN / DYNAGEN /AUTOGEN /MOMENTUM /VIGILANT/ PERCIVA / RESONATE/ Implantable Cardioverter Defibrillator (ICD)3PMA Approval
- P960040ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE, PERCIVA, PUNCTUA, ENERGEN, INCEPTA , Inplantable Cardiov3PMA Approval
- P110042EMBLEM SICD GEN 2, SICD EMBLEM MRI , Subcutaneous Implantable Cardioverter Defibrillator (SICD)3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Pro3PMA Approval
- P910073Plasma Treatment System3PMA Approval
- P960040Autogen, Dynagen, Inogen, Origen (NG3 ICDs), Momentum, Vigilant, Perciva, Resonate (NG4 ICDs)3PMA Approval
- P110042Emblem S-ICD System Model A209 / Emblem MRI S-ICD System Model A2193PMA Approval
- P980016Evera MRI DF-I ICD,EVERA MRI ICD, Evera S DR/S VR/XT DR/ XT VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maxmo II ICD,3PMA Approval
- P110042EMBLEM Subcutaneous Implantable Defibrillator (S-ICD)3PMA Approval
- P960040SMART-MSP3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+ familyof ICD's3PMA Approval
- P910023Fortify, Fortify Assura, Quadra Assura, Ellipse3PMA Approval
- P110042EMBLEM S-ICD3PMA Approval
- P980016Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /XT VR ICD's; Visia AF MRI DFI ICD / AF MRI VR ICD / AF VR ICD.3PMA Approval
- P960040Autogen, Dynagen, Inogen,Origen / NG3 Implantable Cardiac Defibrillators / Momentur, Vigilant, Perciva, Resonate / NG4 I3PMA Approval
- P980016En Trust ICD, Intrinsic ICD, Marquis DR & VR ICD, Maximo II DR ICD, Maximo II ICD, Maximo VR ICD, Protecta ICD /XT ICD,3PMA Approval
- P980016Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD/Visia AF MRI VR ICD/Visia AF VR ICD3PMA Approval
- P980016Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD/Visia AF MRI VR ICD/Visia AF VR ICD3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic +, Atlas/II/+, Convert/+, Photon3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs3PMA Approval
- P980016Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD/Visia AF MRI VR ICD/Visia AF VR ICD3PMA Approval
- P910023Fortify / Fortify Assura / Ellipse3PMA Approval
- P950022Durata and Optisure High Voltage Lead3PMA Approval
- P950022Durata and Optisure Family of High Voltage Leads3PMA Approval
- P910023Current+ CD1211-36, CD2211-36, CD1211-36Q, CD2211-36Q; Fortify CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Ass3PMA Approval
- P110042EMBLEM Subcutaneous Implantable Defibrillator (S-ICD)3PMA Approval
- P960040ICDs: PUNCTUA, ENERGEN, INCEPTA3PMA Approval
- P980016Evera MRI DF ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD - Visia AF MRI DFI ICD, AF MRI VR ICD, AF VR ICD3PMA Approval
- P110042Model 3501 EMBLEM S-ICD subcutaneous Electrode3PMA Approval
- P960040ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE; Implantable Cardioverter Defibrillator(ICD)3PMA Approval
- P910023Fortify, Fortify Assura3PMA Approval
- P960040ICDs: Origen, Inogen, Dynagen, Momentum EL ICD, Autogen, Vigiliant EL ICD, Perciva ICD, Resonate EL ICD, Perciva HF ICD,3PMA Approval
- P980016Maximo II ICD, Protecta ICD, Protecta VR ICD, Protecta XT ICD, Secura DR ICD, Secura ICD, Virtuoso II DR/VR ICD3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P950022TVL(TM) LEAD SYSTEM3PMA Approval
- P960040RESONATE, VIGILANT, PERCIVA NG4 ICDs AUTOGEN, DYNAGEN, INOGEN, ORIGEN NG3 ICDs3PMA Approval
- P910077Multi-Application Utility Model, (Non-Implantable Accessories)3PMA Approval
- P910073ENDOTAK RELIANCE™, (Defibrillation Leads)3PMA Approval
- P910023Ellipse. Fortify Assura, Fortify, Current Accel, Current+, Current ICDs3PMA Approval
- P910023Current+, Fortify, Fortify Assura, Ellipse3PMA Approval
- P960040Torque Wrench3PMA Approval
- P110042Torque Wrench3PMA Approval
- P910077LATITUDE™ Programming System3PMA Approval
- P960040Teligen, Energen, Puntua, Incepta, Origen, Inogen, Dynagen, Autogen3PMA Approval
- P110042S-ICD (Subcutaneous-ICD) Telemetry Wand3PMA Approval
- P980016EVERA MRI DF-1/ DF-1 ICD/MRI ICD/ EVERA XT DR ICD/ VR ICD; PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR ICD; VISIA AF3PMA Approval
- P110042ICD; S-ICD, EMBLEM S-ICD MRI3PMA Approval
- P960040ICDS: ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE HF ICD, RESONATE EL ICD, MOMENTUM EL ICD, VIGILIANT EL ICD, PERCIVA HF3PMA Approval
- P960040NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re3PMA Approval
- P910023Current+ / Fortify / Fortify Assura / Ellipse.3PMA Approval
- P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs3PMA Approval
- P110042Voltage Ceramic Capacitors3PMA Approval
- P110042SQ-RX, Emblem, Emblem MRI S-ICD3PMA Approval
- P110042Emblem Subcutaneous Implantable Cardioverter Defibrillator Pulse Gerator3PMA Approval
- P960040NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re3PMA Approval
- P910077LATITUDE NXT Release Patient Management System3PMA Approval
- P110042Subcutaneous ICD Devices EMBLEM3PMA Approval
- P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PERCIVA, RESONATE, MOMENTUM, VIGILANT3PMA Approval
- P910023Current, Fortify, Fortify Assura3PMA Approval
- P950022Quartet CRT Leads3PMA Approval
- P960040Autogen, Dynagen, Inogen, Origen NG3 ICDs; Resonate, Vigilant, Perciva NG4 ICDs3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016Evera/MRI/DF, ICD, S DR, XT DR, S VR, XT VR, Maximo II ICD, Secura DR ICD/ DR, Visia AF MRI DFI ICD/VR ICD3PMA Approval
- P980016IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P110042Model 2889 EMBLEM S-ICD Automated Screening Tool, v1.013PMA Approval
- P910077MULTIPLE APPLICATION UTILITY MODEL 2909 (FROM V9.03 TO V9.04)3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P960040FINELINE II Lead3PMA Approval
- P980016Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators3PMA Approval
- P910073ENDOTAK RELIANCE IS-1 LEAD3PMA Approval
- P980016Evera MRI DF-1/Evera MRI/Evera S DR/Evera S VR/Evera XT DR/Evera XT VR/Maximo II/Protecta/Protecta VR/Protecta XT/Secura3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P900061Epicardial Patch Lead/Upsizing Sleeve3PMA Approval
- P960040Implantable Cardioverter Defibrillator (ICD) - Origen: D000, D001, D002, D003, D050, D051, D052, D053 - Inogen: D010, D03PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR/ S VR/ XT DR/ XT VR ICD's ; Maximo II ICD; Pritectai I3PMA Approval
- P950022Durata / Optisure ( Passive); / Durata / Optisure (Active)3PMA Approval
- P980016Evera MRI, Evera XT DR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Virtuoso II3PMA Approval
- P980016Evera MRI DF-1 ICD DVMB1D1, DDMB1D1, DDMC3D1, DVMC3D1; Evera MRI ICD DDMC3D4, DVMB1D4, DVMC3D4, DDMB1D4; Evera S DR ICD3PMA Approval
- P980016Evera, Maximo, Protecta, Secura, Solara Quadripolar,Syncra, Viva MRI DF XT ICD CRT-P3PMA Approval
- P110042Subcutaneous Implantable Defibrillator (S-ICD) EMBLEM MRI, S-ICD Gen 2.3PMA Approval
- P960040Implantable Cardioverter Defibrillator (ICD) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOMENTUM, VIGI3PMA Approval
- P980023Plexa S 60/Plexa SD 60/16/Plexa ProMRI S/Plexa ProMRI SD/Plexa DF-1 S/Plexa DF-1 SD/Plexa ProMRI DF-1 SD/Plexa ProMRI DF3PMA Approval
- P110042EMBLEM S-ICD Pulse Generator (PG) & MRI S-ICD Pulse Generator (PG) (S-ICD's)3PMA Approval
- P110042Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App3PMA Approval
- P960040Implantable Cardioverter Defibrilllator/ Dynagen, Inogen, Origen and Autogen ICD's.3PMA Approval
- P980016Evera, Maximo, Protecta, Secura, Visia MRI VR/XT/DR/AF ICD3PMA Approval
- P910023Cadence(R) Tiered Therapy Defribilation System3PMA Approval
- P960040NG4 Family of Pulse Generators ICDS.3PMA Approval
- P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Max3PMA Approval
- P980016Evera, Visia MRI ICD, S VR ICD, XT VR ICD3PMA Approval
- P980016EVERA MRI XT DR SURESCAN MODELS DDMB1D4, EVERA MRI ST VR SURESCAN MODEL DVMB1D4, VISIA AF MRI VR SURESCAN DVFC3D4 IMPLAN3PMA Approval
- P980016Evera MRI XT DR /VR SureScan; Evera MRI S DR/VR SureScan; Visia AF MRI XT Surescan; Visia AF MRI S VR Surescan DVFC3D4 A3PMA Approval
- P980016Evera MRI DF-1/Evera MRI/Evera S DR/Evera S VR/Evera XT DR/Evera XT VR/Maximo II/Protecta/Protecta VR/Protecta XT/Secura3PMA Approval
- P110042All Flex 4-Socket Hi-POT/Pulse Test System3PMA Approval
- P960040Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen ICD Devices3PMA Approval
- P910077LATITUDE™ NXT Patient Management System/ LATITUDE NXT G2 Communicator3PMA Approval
- P910073ACUITY X4 Lead3PMA Approval
- P110042EMBLEM SUBCUTANEOUS ICD's3PMA Approval
- P910077LATITUDE NXT Release 5.03PMA Approval
- P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA ICD's3PMA Approval
- P980016Evera MRI DF-I ICD/Evera MRI ICD/ Evera S DR ICD/Evera S VR ICD/ Evera XT DR ICD/ Evera XT VR ICD/ Visia AF MRI DF1 ICD/3PMA Approval
- P110042EMBLEM™ S-ICD Model A209; EMBLEM™ MRI S-ICD Model A2193PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P980016Evera MRI ICD, Evera S DR/ S VR ICD's; Evera XT DR ICD/ XT VR ICD; Maximo II ICD; Protecta VR/XT ICD; Secura DR ICD, Sec3PMA Approval
- P950022Durata, Durata, Optisure3PMA Approval
- P910023Current+, Fortify, Fortify Assura, Ellipse, Promote+3PMA Approval
- P980023Kainox VCS; Linox TD 65/18 & 65/16; SD 75/18, 65/18, 65/18, 60/16; T65, S75,S65, S60; S DX 65/17; S DX 65/15; Protego DF3PMA Approval
- P950022Durata and Optisure Leads (HV Active and Passive)3PMA Approval
- P110042Emblem S-ICD Programmer - Plexus SMT Mfg. Line3PMA Approval
- P950022Durata and Optisure leads (HV Active and Passive)3PMA Approval
- P980016Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Visia AF MRI DF1, Visia AF MRI VR, Visia AF3PMA Approval
- P980016Evera MRI DF-1, Protecta XT ICD3PMA Approval
- P980016Evera MRI DF-1 ICD/ Evera MRI ICD/Evera S DR ICD/ Evera S VR ICD/ Evera XT DR ICD/Evera XT VR ICD/ Visia AF MRI DF1 ICD/3PMA Approval
- P110042Subcutaneous Implantable Defibrillator (S-ICD) System.3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P980016Evera MRI DF-1/Evera MRI/Evera S DR/Evera S VR/Evera XT DR/Evera XT VR/Maximo II/Secura DR/Serura/Virtuoso II DR/VR/Visi3PMA Approval
- P910023CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q, CD1257-40, CD1257-40Q, CD2257-40, CD2257-40Q, CD1357-40, CD1357-40C, CD1353PMA Approval
- P950022DURATA AND OPTISURE LEADS (HV ACTIVE AND PASSIVE)3PMA Approval
- P910023CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICDS3PMA Approval
- P950022DURATA AND OPTISURE LEADS (HV ACTIVE AND PASSIVE)3PMA Approval
- P980016Evera MRI DF-1ICD DDMB1D1, DDMC3D1 L; Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4;3PMA Approval
- P980016Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT,3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM EMBLEM3PMA Approval
- P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN3PMA Approval
- P910077LATITUDE™ NXT Patient Management System, LATITUDE Wave Communicator3PMA Approval
- P960040DYNAGEN, INOGEN, ORIGEN, AUTOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)3PMA Approval
- P110042EMBLEM SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD)3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P900061EPICARDIAL PATCH LEAD3PMA Approval
- P980016Visia AF software SW035 Version 8.13PMA Approval
- P980023LINOX SMART/PROTEGO (ProMRI) S 65;LINOX SMART/PROTEGO (ProMRI) S 75;LINOX SMART/PROTEGO (ProMRI) SD 65/16;LINOX SMART/PR3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P980016EVERA MRI DF-1 ICD, EVERA MRI IDC, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, VISIA AF MRI DF1 IC3PMA Approval
- P910023LWS, OSR3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P950022Durata and Optisure leads3PMA Approval
- P960040Incepta, Energen, Punctua, Autogen, Dynagen, Inogen, Origen, Resonate, Vigilant, Momentum, and Perciva ICDs3PMA Approval
- P110042Emblem and Emblem MRI S-ICDs3PMA Approval
- P910073ENDOTAK RELIANCE SYSTEM3PMA Approval
- P950022DURATA AND OPTISURE LEADS (HV ACTIVE AND PASSIVE)3PMA Approval
- P110042BUZZER COMPONENT3PMA Approval
- P980016Evera MRI, S DR, S VR, XT DR, XTVR ICD's; Maximo II ICD; Protecta VR, XT ICDs; Secura DR ICD's; Virtuose II DR/VR ICD; V3PMA Approval
- P980023PLEXA S 60, PLEXA SD 60/16, PLEXA PROMRI S 65, PLEXA PROMRI S 75, PLEXA PROMRI SD 65/16, PLEXA PROMRI SD 65/18, PLEXA PR3PMA Approval
- P960040IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM, NG2.5, DYNAGEN, INOGEN, ORIGEN MINI ICD's3PMA Approval
- P910023ELLIPSE3PMA Approval
- P980016EVERA MRI ICD/ S DR/ S VR/ XT DR / XTVR ICD; MAXIMO II ICD ; VIVA QUAD XT CRT-D; VIVA S CRT-D; VIVA XT CRT-D3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)3PMA Approval
- P980023Protego TD 75/18, 65/18, 65/16; T 65; SD 75/18, 65/18, 65/16, 60/16, S75, S65, S60; Protego DF-1 TD 75/18, 65/18, 65/16;3PMA Approval
- P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P980050Transvene CS/SVC Lead3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P960040AUTOGEN EL ICD MODELS D160, D161, D162, D163.3PMA Approval
- P910077LATITUDE NXT System3PMA Approval
- P110042EMBLEM™ MRI S-CD Pulse Generator (PG) Model A219, EMBLEM™ S-CD Pulse Generator (PG) Model A2093PMA Approval
- P980016Evera MRI XT DR, VR, S DR, S VR SureScan ICD; Visia AF MRI XT, S VR SureScan ICD3PMA Approval
- P950022Durata Family Of High Voltage Leads3PMA Approval
- P910023CURRENT AND FORTIFY FAMILY OF ICD DEVICES3PMA Approval
- P980016Evera MRI; S DR,VR;XT DR,VR, ICD; Intrinsic 30 ICD; Marquis VR ICD; Maximo II ICD; Protecta XT ICD; Secura ICD; Virtuoso3PMA Approval
- P980016Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M3PMA Approval
- P950022Durata and Optisure Leads3PMA Approval
- P980016Evera S DR,VR ICD; Evera XT DR, VR ICD3PMA Approval
- P900061END CAP/UPSIZING SLEEVE3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD)3PMA Approval
- P980016Evera MRI, S DR, S VR, XT DR, XT VR ICD's; Visia AF MRI VR ICD & Visia AF VR ICD3PMA Approval
- P980016Evera MRI, S DR, S VR, XT DR, XT VR ICD'S; Maximo Ii ICD; Protecta ICD, XT ICD; Secura DR ICD, Secura ICD; Virtuoso II D3PMA Approval
- P980016MAXIMO II/PROTECTA/PROTECTA VR/PROTECTA XT/SECURA DR/SECURA/VIRTUOSO II DR/VR ICDs3PMA Approval
- P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR DEVICE (S-ICD) SYSTEM EMBLEM3PMA Approval
- P960040IMPLANTABLE CARDIOVETER DEFIBRILLATOR, DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA MINI, EL, ICD3PMA Approval
- P960040ORIGEN EL, INOGEN EL, DYNAGEN EL NG3 ICD;ORIGEN MINI, INOGEN MINI, DYNAGEN MINI NG2.5 ICD; INCEPTA, ENERGEN, PUNCTUA PRO3PMA Approval
- P110042EMBLEM AND EMBLEM MRI S-ICD SYSTEM3PMA Approval
- P980016EVERA MRI XT DR SURESCAN MODEL DDMB1D1, EVERA MRI XT VR SURESCAN MODEL DVMB1D1, EVERA MRI S DR SURESCAN MODEL DDMC3D1, E3PMA Approval
- P980016Evera S, Maximo II, Protecta, Secura,Quad XT CRT-D; Virtuoso II, Visia AF, MRI VR ICD,3PMA Approval
- P980023Permanent defibrillator electrodes3PMA Approval
- P900061Patient Magnet3PMA Approval
- P980016Patient Magnet3PMA Approval
- P110042EMBLEM; EMBLEM MRI (S-ICD)3PMA Approval
- P960040ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA ICDS3PMA Approval
- P910073ENDOTAK RELIANCE 4-SITE, Defibrillation Lead Family ,Active Fixation Models (New): 0272, 0273. Passive Fixation Models (3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980016Evera MRI, S DR, S VR, XT DR, XT VR ICD's; Visia AM MRI VR ICD and Visia AF VR ICD3PMA Approval
- P960040NG3 Implantable Cardioverter Defibrillator (ICD), ORIGEN, INOGEN, DYNAGEN EL ICD'S; NG2 Implantable Cardioverter Defibri3PMA Approval
- P110042EMBLEM S-ICD SYSTEM & EMBLEM MRI S-ICD SYSTEM3PMA Approval
- P980016Evera MRI/S DR/S VR/XT DR/XT VR, Intrinsic 30, Marquis VR, Maximo II, Protecta/Protecta VR/XT, Secura/Secura DR, Virtuo3PMA Approval
- P910023ELLIPSE FAMILY OF ICDS3PMA Approval
- P980016Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1D4,Evera MRI S DR SureScan Model DDMC3D4, Ev3PMA Approval
- P910023FORTIFY ASSURA VR, FORTIFY ASSURA DR3PMA Approval
- P980016EnTrust, Gem,Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Protecta DF4, Protecta, Protecta XT DF4 Prote3PMA Approval
- P980023Protego SD 60/16, Protego SD 65/16, Protego SD 65/18, Protego SD 75/18, Protego TD 65/16, Protego TD 65/18, Protego TD 73PMA Approval
- P910073ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS AND G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS3PMA Approval
- P110042Emblem SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P960040Dynagen EL & Mini, Inogen EL & Mini, Origen EL & MIni IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM3PMA Approval
- P980016Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P980016GEM II DR/GEM II VR/GEM III DR/GEM III VR/ENTRUST/INTRINSIC 30/INTRINSIC/MARQUIS DR/MARQUIS VR/MAXIMO II DR/MAXIMO II/MA3PMA Approval
- P980050GEM III AT ICD3PMA Approval
- P910073ENDOTAK RELIANCE 4-SITE LEADS PASSIVE FIXATION & ENDOTAK RELIANCE 4-SITE ACTIVE FIXATION3PMA Approval
- P110042EMBLEM S-ICD SYSTEM3PMA Approval
- P960040DYNAGEN, INOGEN, ORIGEN ICD'S3PMA Approval
- P960040DYNAGEN™ EL ICD: D150, D151, D152, D153; INOGEN™ EL ICD: D140, D141, D142, D143; ORIGEN™ EL ICD: D050, D051, D052, D053;3PMA Approval
- P980016Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Visia AF MRI VR ICD DVFB1D4, DVFC3D4; Visia AF VR ICD DVAB1D1, DVAB1D43PMA Approval
- P910073ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE LEAD3PMA Approval
- P910023CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICD'S3PMA Approval
- P960040Dynagen™ Models: D020, D021, D022, D023; D150, D151, D152, D153; Inogen™ Models: D010, D011, D012, D013, D140, D141, D143PMA Approval
- P910023Current+ ICDS3PMA Approval
- P950022DURATA, OPTISURE3PMA Approval
- P980016EVERA MRI/EVERA S DR/EVERA S VR/EVERA XT DR/EVERA XT VR/MAXIMO II/PROTECTA/PROTECTA VR/PROTECTA XT/SECURA DR/SECURA/VIRT3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P900061END CAP, UPSIZING SLEEVE3PMA Approval
- P110042SUBCUTANEOUS ICD DEVICES: EMBLEM.3PMA Approval
- P960040ICD DEVICES: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, OPRIGEN, INOGEN, DYNAGEN, AUTOGEN.3PMA Approval
- P910077LATITUDE NXT RELEASE 4.1.13PMA Approval
- P910023Ellipse/Fortify Assura Family of ICDs3PMA Approval
- P910073ENDOTAK LEAD SYSTEM3PMA Approval
- P910077VENTAK PRX and VENTAK MINI ICD Families3PMA Approval
- P830060VENTAK ICD Family3PMA Approval
- P940008RES-Q and RES-Q MICRON ICD and ICD Lead Family3PMA Approval
- P930035VENTAK(R) P2 ICD FAMILY3PMA Approval
- P960040ORIGEN ™ EL ICD: D050, D051, D052, D053; INOGEN ™ EL ICD: D140, D141, D142, D143; DYNAGEN ™ EL ICD: D150, D151, D152, D13PMA Approval
- P980016EVERA MRI, EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR, VISIA AF MRI VR, VISIA AF VR ICD.3PMA Approval
- P980016Maximo II ICD D264DRM, D264VRM, D284VRC, D284DRG; Protecta ICD D334DRG, D334VRG, D334DRM, D334VRM; Protecta XT ICD D314D3PMA Approval
- P980016EVERA MRI ICD, VISTA AF MRI VR ICD, VISIA AF VR ICD3PMA Approval
- P960040NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD). ORIGEN , INOGEN, DYNAGEN EL ICD'S. NG2.5 IMPLANTABLE CARDIOVERTER DEFIB3PMA Approval
- P980016EVERA MRI, S DR ,S VR, XT DR , XT VR ICD'S; MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR3PMA Approval
- P980016Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P960040NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ORIGEN EL ICD: D050, D051, D052, D053 INOGEN EL ICD: D140, D141, D142,3PMA Approval
- P910023CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+, FAMILY OF ICDS3PMA Approval
- P960040Origen, Dynagen, Inogen EL ICD; Origen, Dynagen, Inogen MINI ICD3PMA Approval
- P980016EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT CR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA X3PMA Approval
- P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM3PMA Approval
- P980016EVERA MRI ICD, S DR ICD, S VR ICD, XT DR ICD, ST VR ICF, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECT ICD, S3PMA Approval
- P980023Drug-Eluting Permanent Defibrillator Electrodes, Accessories to Implantable Pacemaker Pulse Generator3PMA Approval
- P950022Durata and Optisure HV leads3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P910073ENDOTAK RELIANCE IS-1 AND ENDOTAK RELIANCE 4-SITE LEAD MODELS3PMA Approval
- P910023CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE3PMA Approval
- P980016EVERA MRI XT DR/VR SURESCAN,EVERA MRI S DR/VR SURESCAN ICDS AND PROGRAMMER SOFTWARE3PMA Approval
- P920015SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935M,SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947M3PMA Approval
- P910073ENDOTAK RELIANCE™ G/SG with 4-SITE™ Connector Defibrillation Leads, Passive Fixation Lead Models: 0265, 0266, 0282, 02833PMA Approval
- P980016VISIA AF VR, VISIA AF MRI VR SURESCAN, EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, P3PMA Approval
- P980016Evera MRI ICD DDMB1D4, DDMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1; Evera XT DR ICD DDBB1D1, DDBB1D3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P910023CURRENT+ ELLIPSE, FORTIFY ASSURA FAMILIES OF THE ICD DEVICES3PMA Approval
- P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM3PMA Approval
- P980016EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,VISIA AF VR,VISIA AF S VR,VISIA AF MRI VR SU3PMA Approval
- P960040Dynagen, Inogen, Origen Implantable Cardiac Defibrillators (ICDs)3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P960040ORIGEN ™ EL ICD D050, D051, D052, D053; ORIGEN ™ MINI ICD D000, D001, D002, D003; DYNAGEN ™ EL ICD D150, D151, D152, D153PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P980016Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D43PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P980016EVERA MRI; EVERA S DR;EVERA XT DR; EVERA XT VR; MAXIMO II; PROTECTA; PROTECTA XT; SECURA ICDS3PMA Approval
- P960040Dynagen™ Models D150, D151, D152, D153; Inogen™ Models D140, D141, D142, D143; Origen™ Models D050, D051, D052, D053 ICD3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P960040IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NG3 EXTENDED LIFE ICD: DYNAGEN, INOGEN, ORIGEN, NG2 5 MINI ICD DYNAGEN, INOGEN,3PMA Approval
- P010012CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT3PMA Approval
- P980016EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO 11 ICD, VIVA AF VR ICD, VISIA AF3PMA Approval
- P980016Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever3PMA Approval
- P980016Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever3PMA Approval
- P980016Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever3PMA Approval
- P910023Ellipse DR Models CD2311-36, CD2311-36Q, CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC; Ellipse VR Models CD1311-36, CD3PMA Approval
- P980016EVERA MRI, EVERA, MARQUIS, SECURA, MAXIMO II, INTRINSIC, PROTECTA, PROTECTA XT, VIRTUOSO II3PMA Approval
- P910073RELIANCE 4-SITE LEAD FAMILY3PMA Approval
- P910023ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S3PMA Approval
- P920015SPRINT QUATTRO LEAD ; SPRINT QUATTRO LEAD3PMA Approval
- P910023CURRENT+ FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES3PMA Approval
- P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES3PMA Approval
- P110042EMBLEM (SUBCUTANEOUS ICD DEVICES)3PMA Approval
- P980016EVERA S DR,S VR XT DR, XT VE,ICD'S; MAXIMO II ICD,. PROTECTA ICD & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P920015SPRINT QUATTRO LEADS3PMA Approval
- P920015SPRINT QUATTRO3PMA Approval
- P920015SPRINT QUATTRO SECURE S MRI SURESCAN ; SPRINT QUATTRO SECURE MRI SURESCAN3PMA Approval
- P920015SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD, HV SPLITTER/ADAPTOR KIT3PMA Approval
- P900061EPICARDIAL PATCH LEAD3PMA Approval
- P980016EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD. EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA X3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P900061EPICARDIAL PATCH LEAD3PMA Approval
- P980016VISIA AF VR , S VR, AFMRI VR SURESCAN, PROGRAMMER SOFTWARE, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P920015SPRINT QUATTRO SECURE S MRI SURESCAN LEAD, SPRINT QUATTRO SECURE MRI SURESCAN LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P920015SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD; TRANSVENE CS/SVC LEAD3PMA Approval
- P980016EVERA MRI ,EVERA, MARQUIS, SECURA, MAXIMO II, INTRINSIC, PROTECTA, PROTECTA XT, VIRTUOSO3PMA Approval
- P920015MEDTRONIC MODEL 5019 HV SPLITTER/ADAPTOR3PMA Approval
- P920015SPRINT QUATTRO MODEL 6946M LEAD3PMA Approval
- P910023CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)3PMA Approval
- P980016EVERA MRI ICD, MARQUIS, SECURA, MAXIMO II, INTRINSIC,PROTECTA, PROTECTA XT, VIRTUOSO II3PMA Approval
- P980016EVERA MRI ICD, S DR, XT DR ICD, XT VR ICD, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT IC3PMA Approval
- P910023CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+FAMILY OF ICDS3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUISI II DR/VR ICD3PMA Approval
- P110042EMBLEM S-ICD SYSTEM3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XI ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P910073ENDO RELIANCE/ S/G/SG/DF4 DEFIBRILLATION LEADS3PMA Approval
- P110042EMBLEM S-ICD PULSE GENERATOR3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT ICD,MAXIMO II ICD, PROTECTA ICD, PROTECT XT ICD,SEC3PMA Approval
- P980016EVERA MRI ICD, EVERA S DR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTS ICD, PROTECTS XT ICD, SECURA IC3PMA Approval
- P110042GEN 2 S-ICD & SQ-RX PULSE GENERATOR, SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFRILLATOR3PMA Approval
- P110042EMBLEM S-ICD PULSE GENERATOR3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD, GEM II VR ICD,GEM III VR ICD,I3PMA Approval
- P980050JEWEL AF ICD3PMA Approval
- P900061MEDTRONIC GEM ICD,MEDTRONIC JEWEL ICD,MEDTRONIC JEWEL PLUS ICD,MEDTRONIC MICRO JEWEL ICD,MEDTRONIC MICRO JEWEL II ICD,ME3PMA Approval
- P920015MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P980016EVERA MRI XT DR SURESCAN ICD, EVERA MRI XT VR SURESCAN ICD,EVERA MRI S DR SURESCAN ICD, EVERA MRI S VR SURESCAN ICD3PMA Approval
- P910023CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P110042EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD )3PMA Approval
- P980016ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II. INSYNC MARQUIS, PROTECTA/ PROTECTA XT DR3PMA Approval
- P920015DF-1 CONNECTOR PORT PIN PLUG,IS-1 CONNECTOR PORT PIN PLUG KIT,SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEA3PMA Approval
- P900061END CAP,UPSIZING SLEEVE3PMA Approval
- P010012DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D3PMA Approval
- P910023CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS3PMA Approval
- P920015SPRINT QUATTRO SECURE S MRI SURESCAN AND SPRINT QUATTRO SECURE MRI SURESCAN3PMA Approval
- P980016EVERA MRI XT DR, XT VR, S DR, S VR SURESCAN ICD'S3PMA Approval
- P910023CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P980016EVERA S DR .S VR, XT DR, XT VR ICD'S, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P910023CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES; MERLIN.NET SYSTEM AND MERLIN@HOME3PMA Approval
- P910023ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S3PMA Approval
- P110042GENE2.0 S-ICD: A2093PMA Approval
- P980016EVERA S DR,SVR, XT DR.XT VR ICD'S; MAXIMO II ICD, PROTECTA ICD & XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016EVERA S DR ICD, S VR ICD; EVERA XT DR ICD, XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PRO3PMA Approval
- P980016ENTRUST, GEMFAMILY, INTRINSCI, MARGUIS, MAXIMO FAMILY, ONYX, PROTECTA FAMILY,SECURA FAMILY,VITITUSO, EVERA FAMILY3PMA Approval
- P920015PCD3PMA Approval
- P900061GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II PCD3PMA Approval
- P980050JEWEL AF, GEM III AT3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P920015HV SPLITTER/ADAPTOR KIT, SPRINT QUATTRO LEAD, SPRINT QUATTRO LEAD3PMA Approval
- P110042EMBLEM SUBCUTANEOUS ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P910073ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS3PMA Approval
- P920015TUNNELING TOOL3PMA Approval
- P910023ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980016EVERA S DR/VR, EVERA XT DR/VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICD'S3PMA Approval
- P920015MEDTRONIC PCD, TACHYARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P900061APPLICATION SOFTWARE, MEDTRONIC GEM ICD, MEDTRONIC JEWEL ICD, MEDTRONIC JEWEL PLUS ICD, MEDTRONIC MICRO JEWEL ICD,MEDTRO3PMA Approval
- P980050APPLICATION SOFTWARE AND JEWEL AF ICD3PMA Approval
- P980016APPLICATION SOFTWARE, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD,GEM I3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,3PMA Approval
- P900061END CAP,EPICARDIAL PATCH LEAD ,UPSIZING SLEEVE3PMA Approval
- P980016VIRTUOSO,SECURA, MAXIMO II ,VIRTUOSO II , PROTECTA XT ,PROTECTA VT,EVERA (XT/S) ,EVERA S AND XT VR AND DR'S3PMA Approval
- P910023CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P910023CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980016MAXIMO II, PROTECTA, PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S3PMA Approval
- P010031CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, & PROTECTA XT CRT-D'S3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P910073ENDOTAK RELIANCE S, ENDOTAK RELIANCE G/SG, ENDOTAK RELIANCE 4-SITE LEAD FAMILY3PMA Approval
- P980016EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR ICDS3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD,3PMA Approval
- P110042EMBLEM S ICD SYSTEM3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD3PMA Approval
- P980016EVERA S(DR/VR) ICD, EVERA XT (DR/VR) ICD, MAXIMO II ICD, PROTECTA (XT)ICD,SECURA ICD, VIRTUOUSO II(DR/VR) ICD3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980016EVERA S DR, EVERA S VR, EVERA XT DR,EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS3PMA Approval
- P920015SPRINT QUATRO LEAD,SUBCUTANEOUS LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR, EVERA S VR,EVERA XT DR, EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS3PMA Approval
- P980016EVERA S DR & VR ICD, EVERA XT DR & VR ICD, MAXIMO II ICD, PROTECTA ICD & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD,3PMA Approval
- P910023ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S3PMA Approval
- P980016EVERA S DR ICD,VR ICD, XT DR ICD,VR ICD, MAXIMO II ICD, PROTECTA ICD,XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II D3PMA Approval
- P980016EVERA S DR, VR,; EVERA XT DR, EVERA XT VR , MAXIMO II , PROTECTA , PROTECTA XT, SECURA; AND VIRTUOSO II D/RVR ICD'S3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II3PMA Approval
- P910023CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD; VR ICD, EVERTA XT DR ICD; EVERA XT VR ICD, MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD , SECURA ICD; VI3PMA Approval
- P920015SPRINT QUATTRO LEAD, SPRINT QUATTRO LEAD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA XT ICD, PROTECTA XT ICD, SECUR3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO I3PMA Approval
- P910023FORTIFY VR,FORTIFY DR,FORTIFY ASSURA VR, FORTIFY ASSURA DR ICDS3PMA Approval
- P980016EVERA S DR/S VR,XT DR, XT VR ICD; ENTRUST; INTRINSIC 30 & INTRINSIC ICD; MARQUIS DR, VR ICD; MAXIMO DR, II, VR ICD; PROT3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA3PMA Approval
- P910023ELLIPSE / FORTIFY ASSURA FAMILY OF ICD'S3PMA Approval
- P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA IC3PMA Approval
- P910023CURRENT ACCEL, CURRENT+ FAMILES OF ICD DEVICES3PMA Approval
- P980016MAXIMO II,PROTECTA,PROTECTA XT,SECURA AND VIRTUOSO II DR/VR ICDS3PMA Approval
- P910023ELLIPSE/FORTIFY ASSURA FAMILY OS ICD'S3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD3PMA Approval
- P110042CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P910023CURRENT, CURRENT ACCEL, CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICD DEVICES3PMA Approval
- P910023FORTIFY, FORTIFY ASSURA FAMILY OF ICDS3PMA Approval
- P010031, BRAVA QUAD, CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S & XT, VIVA S & XT CRT-D'S3PMA Approval
- P980016EVERA S DR & SR,, EVERA XT DR & VR , MAXIMO II, PROTECTA , PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD, INTRINSIC ICD, MARQUIS ICD,MARQUIS V3PMA Approval
- P910073ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS3PMA Approval
- P900061ACE HEADER3PMA Approval
- P920015TUNNELING TOOL3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P110042CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P920015SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD3PMA Approval
- P910023CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA I3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P910023ELLIPSE FAMILY OF ICDS3PMA Approval
- P920015TUNNELIING TOOL3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P920015VAISALA CONTINUOUS MONITORING SYSTEM3PMA Approval
- P010031CONCERTO II CRT-D, CONCULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P900061EPICARDIAL PATCH LEAD3PMA Approval
- P920015SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD3PMA Approval
- P980016EVERA S DR/VR, EVERA XT DR/VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA , VIRUOSO II DR/VR ICD'S3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P910023ELLIPSE / FORTIFY ASSURA FAMILY OF ICD'S3PMA Approval
- P980016EVERA S D DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P910077VENTAK PRX & VENTAK MINI ICD: LATTITUDE PATIENT MANAGMENT SYSTEM3PMA Approval
- P980016ENTRUST, GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA DF4, PROTECTA, PROTECTA XT DF4,3PMA Approval
- P980050JEWEL AF, GEM III AT3PMA Approval
- P900061GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD3PMA Approval
- P920015PCD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P920015SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P920015SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD3PMA Approval
- P110042CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P960040NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD,ORIGEN EL3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA I3PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD3PMA Approval
- P900061END CAP, EPICARDIAL PATCH LEAD, UPSIZING SLEEVE3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICS, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO 11 ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II D3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P910023ELLIPSE FAMILY OF ICDS3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P910077VENTAK PRX AND VENTAK MINI3PMA Approval
- P830060VENTAK3PMA Approval
- P930035VENTAK P2 PACEMAKER3PMA Approval
- P910073ENDOTAK LEAD SYSTEM3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P910023FAMILY OF MERLIN@HOME TRANSMITTERS3PMA Approval
- P980016EVERA S DR IC&, VR, XT DR, & XT VR ICD, MAXIMO II ICD, PROTECTA & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P910023FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P980016MAXIMO II, PROTECTA, PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S3PMA Approval
- P910077LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.03PMA Approval
- P960040TELIGEN, PROGENY ICD AND NG ICD MODELS3PMA Approval
- P980016MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD AND MAXIMO VR ICD3PMA Approval
- P910023CURRENT, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILIES OF ICD DEVICE3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD; EVERA XT DR. ICD; EVERA XT VR IC D; MAXIMO II ICD; PROTECTA ICD' SECURA ICD, VIRTUOSO II3PMA Approval
- P980016MAXIMO II DR,MAXIMO II VR,VIRTUOSO II VR,SECURA DR,SECURA VR3PMA Approval
- P910073ENDOTEK RELIANCE DF1/IS-1 AND RELIANCE 4-SITE LEAD FAMILIES3PMA Approval
- P110042SUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P110042CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P980049PARADYM RF VR 9250, VR9250, PARADYM RF DR 95503PMA Approval
- P980049PARADYM VR ICD, DR ICD, RF VR ICD, RD DR ICD, ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS3PMA Approval
- P910023CURRENT+, FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S3PMA Approval
- P980016PROTECTA ICD & PROTECTA XT ICD3PMA Approval
- P910023ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD3PMA Approval
- P910077LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD , EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P910023FORTIFY AND FORTIFY ASSURA ICDS3PMA Approval
- P980016EVERA S DR ICD, VR ICD, XT DR ICDXT VR ICD, MAXIMO II ICD PROTECTA ICD, XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016EVERA S DR ICD; S VR ICD; EVERA XT DR ICD; XT VR ICD; MAXIMO II ICD; PROTECTA ICD; XT ICD; SECURA ICD; VIRTUOSO II DR/VR3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR3PMA Approval
- P110042CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD,INTRINSIC ICD,MARQUIS DR ICD, MARQUIS3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM, Q-GUIDE ELECTRODE INSERTION TOOL3PMA Approval
- P910023ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS3PMA Approval
- P910023CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD,INTRINSIC 30 ICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P910023FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P980016EN TRUST, VIRTUSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II, INSYNC MARQUIS, PROTECTA DR,XT, DR, PROT3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P940008RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS3PMA Approval
- P910073ENDOTAK TRANSVENOUS DEFIBRILLATION SYSTEM3PMA Approval
- P830060AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM3PMA Approval
- P910077VENTAK PRX AICD SYSTEM. PRESCRIPTOR PROGRAMMER AND PROGRAM AND PROGRAM DISK3PMA Approval
- P930035VENTAK P2 AICD SYSTEM3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD3PMA Approval
- P830060AID-B/BR AND VENTAK ICD3PMA Approval
- P910077VENTAK PRX, VENTAK MINI FAMILIES OF ICDS3PMA Approval
- P910073ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS3PMA Approval
- P110042CAMERON HEALTH SUBSUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P110042CAMERON HEALTH SUBCUTANEOUSIMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P980016MARQUIS DR 7274; MARQUIS VR 7230B/7230X/723E; MAXIMO DR7278; MAXIMO VR 72323PMA Approval
- P910073RELIANCE IS-1/DF-1 LEAD FAMILY,RELIANCE 4-SITE LEAD FAMILY3PMA Approval
- P980016VIRTUOSO DR, VIRTUOSO VR, SECURA DR AND MAXIMO II DR3PMA Approval
- P980016EVERA S DR ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD,PROTECTA ICD, PROTECTA3PMA Approval
- P110042S-ICD SYSTEM3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P960040DYNAGEN EL & MINI ICD'S; INOGEN EL & MINI ICD'S; ORIGEN EL & MINI ICD'S; TELIGEN ICD3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P910023CADENCE/ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S3PMA Approval
- P980049PARADYM VR 8750, PARADYM DR 8750, PARADYM RF CRT-D3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD AND VIRTUOSO II DR VR ICD3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P830060VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM/ LEAD TUNNELER KIT3PMA Approval
- P910023CURRENT,FORTIFY,FORTIFY ASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EGMP5 DOWNLOAD SOFTWARE APPLICATION,EVERA S DR ICD.EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PATIENT3PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD3PMA Approval
- P900061ACE HEADER, CABLE, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, PATIENT MAGNET, UPSIZING SLEEVE3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P110042S-ICD SYSTEM3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD3PMA Approval
- P050023LUMAX 6/7 AND ILESTO/IFORIA ICD/CRT D FAMILIES3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P910023CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P980016EVERA S DR ID, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD3PMA Approval
- P910023CURRENT , ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P910023FORTIFY, FORTIFY ASSURA AND ELLIPSE ICDS3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR/S VR ICD'S, EVERA XT DR/VR ICD'S, MAXIMO II ICD, PROTECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR IC3PMA Approval
- P980016EVERA S DR/VR, EVERA XT DR/VR ICD'S; MAXIMO II ICD; PRTOECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P900061EPICARDIAL PATCH LEAD FAMILY3PMA Approval
- P920015SPRINT QUATTRO LEAD FAMILY3PMA Approval
- P980016ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD, VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT3PMA Approval
- P910023CURRENT, ELLIPSE, FORTIFY, FORTIFYASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016ENTRUST ICD, INTRINSIC 30ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, VR ICD, EVERA S DR ICD, S VR ICD,XT VR ICD, MAXIMO3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR ( S-ICD) SYSTEM3PMA Approval
- P910023FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD3PMA Approval
- P110042CAMERON HEALTH SUBCUTANCOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P920015SPRINT QUATTRO LEAD & HV SPLITTER/ADAPTOR KIT3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980050INCHECK PATIENT ASSISTANCE, TRANSVENE CS/SVC LEAD3PMA Approval
- P980016EVERA S DR , S VR XT DR , XT VR . MAXIMO II , PROTECTA, XT ICD, RV, SECURA, VIRTUOSO II DR/VR ICDS/3PMA Approval
- P900061ACE HEADER, APPLICATION SOFTWARE, DEFRILLATION SUPPORT DEVICE (DISD) END CAP, EPICCARDIAL PATCH LEAD SIZILING SLEEVE UPS3PMA Approval
- P920015SPRINT QUATTRO & TRANSVENE CS/SVC LEADS3PMA Approval
- P900061EPICARDIAL PATCH LEAD3PMA Approval
- P920015SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE SVC LEAD3PMA Approval
- P980016MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRTUOSO II DR/VR IC3PMA Approval
- P980050TRANSVENE LEAD3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P900061EPICARDIAL PATCH LEAD3PMA Approval
- P910023CURRENT,CURRENT ACCEL,CURRENT +,ELLIPSE,FORTIFY,FORTIFY ASSURA FAMILIES OF ICD DEVICES3PMA Approval
- P980016EVERA S DR ICD, EVERA VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD3PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D IPG3PMA Approval
- P920015SPRINT QUANTTRO LEAD3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD3PMA Approval
- P920015SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR, EVERA S VR ICD, EVERA XT DR ICD AND EVERA VR ICD3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P110042CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S- ICD SYSTEM3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P900061ACH HEADER, END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE3PMA Approval
- P920015Y ADAPTOR EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CIONNECTIR PORT PIN PLUG, LEAD ADAPTOR, SPRINT QUATTRO LEAD3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P920015TRANSVENE,SQ,SPRINT AND SPRINT FIDELIS LEAD MODELS AND ACCESSORIES3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P920015SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P900061EPICARDIAL PATCH LEAD3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT3PMA Approval
- P110042SUBCUTANEOUS IMPLANABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P010031BRAVA CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVA S CRT-D, VIVA XT CRT-D3PMA Approval
- P980016EVERA S DR ICD. EVERA S VR ICD, EVERA XT DR ICD; EVERA XT VR ICD, PROTECTA ICD, PROCTECTA XT ICD3PMA Approval
- P920015SPRINT QUATTRO ELECTRODE RING SUPPLIER MATERIAL STOCK CHANGE3PMA Approval
- P980016EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECT XT ICD,SECURA ICD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980016ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, INSYNC MARQUIS, PROTECTA XT, DR, PROTEXTA DR, PROTEXTA XT, VR,3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P920015TRANSVENE,SQ,SPRINT AND SPRINT FIDELIS LEAD MODELS AND ACCESSORIES3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD3PMA Approval
- P980016VIRTUOSO DR,VIRTUOSO VR,SECURA DR,MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR,PROTE3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P110042CAMERON HEALTH SUBCUTANCEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P980016ENTRUST,INTRINSIC 30,INTRINSIC,MARQUIS DR,MARQUIS VR,MAXIMO DR,MAXIMO VR ICDS3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P910077VENTAK PRX AND VENTAK MINI AICD3PMA Approval
- P830060VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS3PMA Approval
- P930035VENTAK P2 AICD SYSTEMS3PMA Approval
- P890061VENTAK P AICD SYSTEMS3PMA Approval
- P910073ENDOTAK LEAD SYSTEM3PMA Approval
- P980016PROTECTA XT ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II ICD, MAXIMO II ICD3PMA Approval
- P010031PROTECTA XT CRT-D, PROTECTA CRT-D, CONSULTA CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D3PMA Approval
- P910073ENTOTAK LEAD SYSTEM3PMA Approval
- P920015SPRINT QUATTRO LEAD, SPLITTER/ADAPTOR, DF-4 IMPLANT TOOL KIT FOR MDT LEADS3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT, HV SPLITTER/ ADAPTOR KIT3PMA Approval
- P980016EVERA S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; INTRINSIC ICD; MARQUIS DR ICD, VR ICD; MAXIMO DR ICD, MAXIMO II ICD, MAX3PMA Approval
- P980016EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR ICDS3PMA Approval
- P910077ZOOM LATITUDE PROGRAMMER3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR SYSTEM (S-ICD)3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR/VR & XT DR/ VR, MAXIMO II, PROTECTA/PROTECTA XT, SECURA, VIRTUOSO II DR/ VR ICD'S3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIB RILLATOR (S-ICD) SYSTEM3PMA Approval
- P830060VENTAK3PMA Approval
- P910077VENTAK PRX MINI3PMA Approval
- P910073ENDOTAK LEAD FAMILY3PMA Approval
- P050023LUMAX3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016MAXIMO II ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980050TRANSVENE LEAD3PMA Approval
- P980016EVERA S DR ICD, S VR ICD,XT DR ICD, XT VR ICD, INTRINISIC ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, MAXIMO II ICD; VR3PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR POT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-I CONNECTOR PORT PIN PLUG KIT,3PMA Approval
- P900061ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE3PMA Approval
- P910073RELIANCE IS-1/DF-1,RELIANCE 4-SITE PASSIVE FIXATION LEADS3PMA Approval
- P980016VIRTUOSO DR,VIRTUOSO VR,SECURA DR, MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICDO) SYSTEM3PMA Approval
- P980016EVERA S DR ICD, EVER S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA IC3PMA Approval
- P980016INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD,SECUR3PMA Approval
- P980016EVERA S DR ICD , D VR ICD, ST DR ICD, XT VR ICD; MAXIMO II ICD, PROTECTA ICD/ XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P910077LATITUDE COMMUNICATOR3PMA Approval
- P910077ZOOM LATITUDE PROGRAMMING SYSTEM3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR, ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P980016EVERA S DR ICD, EVERA S VR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD3PMA Approval
- P900061GEM,JEWEL,MOCRO JEWEL,JEWEL PLUS,MICRO JEWEL II,PCD3PMA Approval
- P980016ENTRUST,GEM,GEM II,GEM III,INTRINSIC,MARQUIS,MAXIMO,MAXIMO II,ONYX,PROTECTA DF4,PROTECTA,PROTECTA XT DF4,PROTECTA XT3PMA Approval
- P980050DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR3PMA Approval
- P980050TRANSVENE LEAD3PMA Approval
- P920015SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE SVC LEAD3PMA Approval
- P010031INSYNC II P ROTECT ICD, INSYNC III MARQUIS ICD, INSYNC MARQUIS ICD, INSYNC MAXIMO ICD3PMA Approval
- P980016ENTRUST ICD, INTRINSIC 30 ICD, INTRINSIC ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO VR IC3PMA Approval
- P980016EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR,MAXIMO II,PROTECTA,PROTECTA XT,SECURA,VIRTUOSO II DR/VR ICDS3PMA Approval
- P980016EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD)3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P980016EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR3PMA Approval
- P910073RELIANCE IS-1/DF-1 LEAD AND RELIANCE 4-SITE LEAD3PMA Approval
- P980016INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD, SECURA ICD,VIRTUOS3PMA Approval
- P980016EVERA S DR, EVERA S VR, EVERA XT DR3PMA Approval
- P980016EVERA S DR, EVERA S VR, EVERA XT DR3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM3PMA Approval
- P980016EVERA S DR3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD3PMA Approval
- P9200156947M SPRINT QUATTRO LEAD3PMA Approval
- P920015MODEL 5019 HV SPLITTER/ADAPTOR3PMA Approval
- P980050TRANSVENE LEAD3PMA Approval
- P920015DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE SVC3PMA Approval
- P900061END CAP, SIZING SLEEVE, UPSIZING SLEEVE3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P980016INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD, SECURA ICD,VIRTUOS3PMA Approval
- P980016MAXIMOII ICD, PROTECTA ICD,PROTECTA XT ICD, SECURA ICD, VIRTUOSOII DR/VR ICD3PMA Approval
- P980016MEDTRONIC EVERA XT DR, EVERA XT VR, EVERA S DR, EVERA S VR IMPLANTABLE CARDIOVERTER DEFINRILLATORS3PMA Approval
- P980016SPACE DATA COLLECTOR AND NIKON ROUTER3PMA Approval
- P980016MAXIMOII ICD3PMA Approval
- P980016ENTRUST ICD, PROTECTA DF4 ICD, ICD, XT DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO ICD VIRTUOSO II DR/VR ICD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO DR/VR ICD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD3PMA Approval
- P910077LATITUDE COMMUNICATOR3PMA Approval
- P980016CONCERTO, VIRTUOSO (MODEL SW002 V8.0)3PMA Approval
- P010031CONSULTA CRT-P, ADVISA (MODEL 9995 V8.0) CONSULTA CRT-D, SECURA (MODEL 9995 V8.0) INSYNC III, MAXIMO II, CONCERTO II3PMA Approval
- P110042CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P920015LEAD ADAPTOR/SPRINT QUATTRO/ SPRINT QUATTRO LEAD/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980016ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTO/PROTECTO XT/SECURA/VIRTUOSO/VIRTUOSO II/PROTECTA XT DR/PROTECTA DR3PMA Approval
- P900061UNIPOLAR/ LEAD END PIN CAP/OVAL PATCH LEAD3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P910073ENDOTAK RELIANCE, ENDOTAK RELIANCE 4-SITE3PMA Approval
- P920015MODEL 5019 HIGH VOLTAGE (HV) SPLITTER/ADAPTOR KIT3PMA Approval
- P910077MULTIPLE APPLICATION UTILITY (MAU) USED WITH ZOOM LATITIDE PROGRAMMING SYSTEM3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016VITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR3PMA Approval
- P910077LATITUDE WAVE COMMUNICATOR (MODEL 6498)3PMA Approval
- P920015SPRINT QUATTRO SECURE LEAD3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT, SPRINT QUATTRO LEAD3PMA Approval
- P010031CONCERTO ICD, II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD,INSYNC MAXIMO ICD, II CRT-D,PROTECTA CRT-D, PROTECTA XT CRT-D3PMA Approval
- P980016ENTRUST ICD,INTRINSIC ICD,MARQUIS DR ICD,VR ICD,MAXIMO II ICD,VR ICD,PROTECTA ICD,XT ICD,SECURA ICD,VIRTUOSO ICD3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P910073ENDOTAK RELIANCE 4-SITE LEAD AND ACCESSORY MODELS3PMA Approval
- P900061ACE HEADER, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE3PMA Approval
- P980050TRANSVENE LEAD3PMA Approval
- P920015Y ADAPTOR /EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SPRINT QUATTRO3PMA Approval
- P980016INTRINSIC ICD, MARQUIS DR ICD, & VR ICD, MAXIMO DR ICD, MAXIMO II ICD & VR ICD, PROTECTA ICD & XT ICD, SECURA ICD3PMA Approval
- P910073RELIANCE 4-SITE DEFIBRILLATOR LEAD3PMA Approval
- P920015SPRINT QUATTRO LEADS3PMA Approval
- P920015SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD3PMA Approval
- P910073RELIANCE IS-1/IS-4 ACTIVE AND PASSIVE FIXATION DEFIBRILATION LEADS3PMA Approval
- P900061JEWEL ICD, JEWEL PLUS ICD, MICRO JEWEL ICD, MICRO JEWEL II ICD, GEM ICD3PMA Approval
- P910073RELIANCE DF4 LEADS3PMA Approval
- P980016GEM II VR ICD,MARQUIS VR ICD,GEM III VR ICD,MAXIMO VR ICD,GEM DR ICD,GEM II DR ICD,MARQUIS DR ICD,GEM III DR ICD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD AND VIRTUOSO II DR/VR ICD3PMA Approval
- P980016MAXIMO II DF4 CRT-D, MAXIMO II DF4 ICD, MAXIMO II ICD, PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT3PMA Approval
- P110042CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM3PMA Approval
- P910077VENTAK PRX AND VENTAK MINI ICD FANILIES3PMA Approval
- P930035VENTAK P2 ICD FAMILIES3PMA Approval
- P910073ENDOTAK AND RELIANCE LEAD FAMILIES3PMA Approval
- P890061VENTAK ICD FAMILIES3PMA Approval
- P830060VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM FAMILY3PMA Approval
- P980016ENTRUSTICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD3PMA Approval
- P910073RELIANCE IS-4 DEFIBRILLATION LEAD3PMA Approval
- P910077LATITUDE/PROGRAMMER/RECORDER/MONITOR3PMA Approval
- P930035VENTAK PRIZM 2 FAMILIES, ICD3PMA Approval
- P830060VENTAK , VENTAK PRIZM, ICD3PMA Approval
- P890061VENTAK PRIZM 2 FAMILIES, ICD3PMA Approval
- P940008RES-Q FAMILY OF ICD/ICD LEADS, RES-Q MICRON FAMILY OF ICDS3PMA Approval
- P910073ENDOTAK FAMILY OF ICD LEADS3PMA Approval
- P910077VENTAK PRX/VENTAK MINI FAMILIES OF ICDS3PMA Approval
- P910077LATITUDE G2 COMMUNICATOR3PMA Approval
- P980016MAXIMO II CRT-D, MAXIMO II ICD, MAXIMO II ICD, PROTECTA ICD AND PROTECTA XT ICD3PMA Approval
- P910073ACUITY SPIRAL3PMA Approval
- P910073ENDOTAK LEAD SYSTEM3PMA Approval
- P980016MAXIMO II DF4CRT-D,MAXIMO II DF4 ICD,MAXIMO II ICD,PROTECTA DF4 ICD,PROTECTA ICD,PROTECTA XT DF4 ICD,PROTECTA XT ICD3PMA Approval
- P980016ENTRUST,SECURA,GEM II/III VR/DR,INTRINSIC/INTRINSIC 30,MAXIMO VR/DR,MAXIMO II,MARQUIS VR/DR,PROTECTA/PROTECTA XT3PMA Approval
- P010031CONCERTA, CONSULTA/CONSULTA DF4, & VARIOUS INSYNC FAMILIES OF ICD'S; CONCERTO II, MAXIMO II,PROTECTA,PROTECTA XT CRT-D'S3PMA Approval
- P980050GEM III AT3PMA Approval
- P920015SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE SVC LEAD, TUNNELLING TOOL3PMA Approval
- P980050TRANSVENE LEAD3PMA Approval
- P910077VENTAK PRX AND VENTAK. MINI AUTOMATIC IMPLANTABLE CARDIOVERTER3PMA Approval
- P910077MODEL 3120 ZOOM LATTITUDE PROGRAMMING SYSTEM3PMA Approval
- P920015SPRINT QUATTRO LEAD, 6935, 6935M, 6944, 6947, 6947M3PMA Approval
- P910077VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) FAMILIES3PMA Approval
- P830060VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY3PMA Approval
- P930035VENTAK P /P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILIES3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P920015SPRINT QUATTRO, SPRINT QUATTRO LEAD3PMA Approval
- P910073ENDOTAK RELIANCE EZ IS-1 AND 4-SITE EZ QUADRIPOLAR ACTIVE FIXATION LEADS3PMA Approval
- P980050TRANSVENE LEAD3PMA Approval
- P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM3PMA Approval
- P980016VIRTUOSO,ENTRUST,MAXIMO,INTRINSIC,MARQUIS,CONCERTO,PROTECTA,SECURA,CONSULTA,GEM,AND ONYX FAMILIES OF ICDS3PMA Approval
- P910077LATTITUDE PATIENT MANAGEMENT SYSTEM3PMA Approval
- P980016PROTECTA ICD, PROTECTA XT ICD3PMA Approval
- P980016MAXIMO II DF-4 CRT-D, MAXIMO II DF-4 ICD, MAXIMO II ICD, PROTECTA DF4-ICD, PROTECTA ICD, PROTECTA XT DF-4 ICD, PROTECTA3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016MAXIMO II DF4 ICD, SECURA DF4 ICD3PMA Approval
- P010031PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D3PMA Approval
- P980016PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016PROTECTA ICD AND PROTECTA XT ICD3PMA Approval
- P980016MAXIMO II ICD, SECURA ICD AND VIRTUOSO II DR/VR ICD3PMA Approval
- P980050TRANSVENE LEAD, 6937 A3PMA Approval
- P980016EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO II ICD, MAXIMO VR ICD, PROTECTA ICD,3PMA Approval
- P900061END CAP 6701,EPICARDIAL PATCH LEAD 6721L, 6721M, 6721S,SIZING SLEEVE 6920,UPSIZING SLEEVE 69253PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SPRINT QUATTRO L3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD,PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016ENTRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II ICD3PMA Approval
- P980016EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II3PMA Approval
- P980016MAXIMO II DF4 CRT-D, DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016MAXIMO II DF4 CRT-D, DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016CONCERTO ICD, CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA DF-DF-4, PROTECTA XT3PMA Approval
- P980016VIRTUOSO II DR/VR ICD & VARIOUS FAMILIES OF MAXIMO II, PROTECTA & SECURA ICDS3PMA Approval
- P980016MAXIMO II, PROTECTA,PROTECTA XT, SECURA AND VIRTUOSO II3PMA Approval
- P980050TRANSVENE LEADS3PMA Approval
- P920015TRANSVENE SVC LEAD3PMA Approval
- P900061EPICARDIAL PATCH LEADS3PMA Approval
- P910073ENDOTAK LEAD SYSTEM3PMA Approval
- P910073ENDOTAK RELIANCE EZ IS-1 ACTIVE FIZATION LEAD MODELS3PMA Approval
- P980050TRANSVENE LEAD, MODEL 6937A3PMA Approval
- P920015SPRINT QUATTRO3PMA Approval
- P920015SPRINT QUATTRO SINGLE COIL DF4, ACTIVE FIXATION LEAD3PMA Approval
- P980016MEDTRONIC DF4 PROTECTA XT/PROTECTA/SECURA/MAXIMO II VR/DR ICDS3PMA Approval
- P980016PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD3PMA Approval
- P910077VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER3PMA Approval
- P980016PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD3PMA Approval
- P980016PROTECTA XT VR DF4, PROTECTA VR DF4, SECURA VR DF4, & MAXIMO II VR DF4 ICD'S3PMA Approval
- P980016SECURA, MAXIMOII, PROTECTA, PROTECTA XT3PMA Approval
- P980016MAXIMO II DF4/ICD, PROTECTA DF4/ICD/XT DF4/XT ICD, SECURA DF4/ ICD & VIRTUOSO II DR/VR ICD3PMA Approval
- P980016MAXIMO II, SECURA & VIRTUOSO II DR/VR ICDS3PMA Approval
- P980016MAXIMO II DF4 & ICD, PROTECTA DF4 & ICD & XT DF4 & XT ICD, SECURA DF4 & ICD, VIRTUOSO II DR/VR ICD3PMA Approval
- P980016CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M43PMA Approval
- P980016CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, MXIMO II M4, PROTECTA CRT-D, PROTECTA M4, XT CRT-D & XT M43PMA Approval
- P980016PROTECTS XT VR, PROTECTA VR, SECURA VR MAXIMO II ICD3PMA Approval
- P980016GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA, SECURA, VIRTUOSO, VITUOSO II, ENTRUST3PMA Approval
- P900061GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD3PMA Approval
- P980050DIVA FAMILY, SELECTION AFM C-SERIES AND T-SERIES DEVICES3PMA Approval
- P980016MAXIMO II, MAXIMO II ICD, PROTECTA, PROTECTA ICD, PROTECTA XT, PROTECTA XT ICD, SECURA, SECURA ICD,VIRTUOSO II DR/VR ICD3PMA Approval
- P940008RES-Q / RES-Q MICRON PULSE GENERATOR SYSTEM FAMILIES3PMA Approval
- P930035VENTAK P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY3PMA Approval
- P830060VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY3PMA Approval
- P890061VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY3PMA Approval
- P910073ENDOTAK LEAD SYSTEM FAMILY3PMA Approval
- P910077VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERSTER DEFIBRILLATOR (AICD) FAMILIES3PMA Approval
- P980016SECURA/MAXIMO II/PROTECTA /PROTECTA XT/ENTRUST/ENTRUST DR3PMA Approval
- P980050GEM III AT3PMA Approval
- P920015SPRINT QUATTRO SECURE /S/SPRINT3PMA Approval
- P980016CAPSURE FIX3PMA Approval
- P980016MAXIMO VR ICD3PMA Approval
- P980016GEM DR3PMA Approval
- P920015TRANSVENE LEADS3PMA Approval
- P980016GEM DR3PMA Approval
- P920015SPRINT QUATTRO SECURE LEAD (DF4)3PMA Approval
- P980050JEWEL AF MODEL 72503PMA Approval
- P9800164195 ATTAIN STARFIX3PMA Approval
- P9000617261A PCD3PMA Approval
- P920015TRANSVENE LEADS3PMA Approval
- P980016ENTRUST / VIRTUOSO / PROTECTA3PMA Approval
- P920015MEDTRONIC SPRINT QUATTRO SECURE DF4 LEAD MODEL 6947M3PMA Approval
- P980016PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR3PMA Approval
- P980016INTRINSIC, MARQUIS DR/VR, & MAXIMO DR/VR ICDS3PMA Approval
- P980016MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM)3PMA Approval
- P980016MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM)3PMA Approval
- P980016INTRINSIC, MARQUIS DR/VR, & MAXIMO DR/VR ICDS3PMA Approval
- P910077ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD3PMA Approval
- P910073ENDOTAK RELIANCE S RX IS-1/EZ IS-1/4-SITE EZ/4-SITE RX LEADS3PMA Approval
- P980016MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/VIRTUOSO II/SECURA/PROTECTA XT/PROTECTA/PROTECTA XT/PROTECTA DF4 ICD3PMA Approval
- P980016MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P980016ENTRUST, MAXIMO II, PROTECTA/PROTECTA XT, SECURA, VIRTUOSO/VIRTUOSO II3PMA Approval
- P940008LEAD TERMINAL CAP3PMA Approval
- P900061OVAL PATCH LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P920015SPRINT QUATTRO/SUBCUTANEOUS LEAD3PMA Approval
- P980016PROTECTA AND PROTECTA XT3PMA Approval
- P980016MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II3PMA Approval
- P980016ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II SECURA/VIRTUOSO II/INSYNC MARQUIS/VIRTUOSO/PROTECTA3PMA Approval
- P980016MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II3PMA Approval
- P910073RELIANCE 4-SITE IS-4 LEADS3PMA Approval
- P920015SPRINT QUATTRO/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD3PMA Approval
- P980050TRANSVENE CS/SVC3PMA Approval
- P900061GEM, PCD, & VARIOUS FAMILIES/MODELS OF JEWEL3PMA Approval
- P980050JEWEL AF, GEM III AT3PMA Approval
- P980016ENTRUST, INTRINSIC, MARQUIS, ONYX, SECURA, & VARIOUS FAMILIES/MODELS OF GEM, MAXIMO, PROTECTA, & VIRTUOSO3PMA Approval
- P980016MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II3PMA Approval
- P980016MEDTRONIC PROTECTA XT DR D314DRM, PROTECTA DR D334DRM, CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P980016MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II3PMA Approval
- P980016ENTRUST; INTRINSIC; MARQUIS; ONYX; SECURA; VARIOUS FAMILIES OF GEM, MAXIMO, PROTECTA, & VIRTUOSO3PMA Approval
- P910023CADENCE/CURRENT FAMILY OF ICDS3PMA Approval
- P980016ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/VIRTUOSO II3PMA Approval
- P980016PROTECTA/PROTECTA XT3PMA Approval
- P910023CADENCE FAMILY OF ICDS3PMA Approval
- P910077VENTAK PRX AND VENTAK MINI AUTOMATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ACID) SYSTEMS3PMA Approval
- P830060VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES3PMA Approval
- P980016MAXIMO II, PROTECTA, PROTECTA XT, SECURA VIRTUOSO II3PMA Approval
- P980016PROTECTA (D334TRG, D334VRG), PROTECTA XT (D314DRG, D314VRG)3PMA Approval
- P980016ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II3PMA Approval
- P010031CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT3PMA Approval
- P030035FRONTIER/FRONTIER II / ANTHEM FAMILY OF CRT-PS3PMA Approval
- P880006SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS3PMA Approval
- P880086AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS3PMA Approval
- P910023CADENCE/CURRENT/FORTIFY FAMILY OF ICDS3PMA Approval
- P970013MICRONY FAMILY OF PACEMAKERS3PMA Approval
- P030054EPIC HF/ATLAS + HF/PROMOTE/UNIFY FAMILY OF CRT-DS3PMA Approval
- P980016CAPSURE; ENTRUST; INTRINSIC; MARQUIS; VARIOUS MODELS OF MAXIMO, VIRTUOSO, & PROTECTA; SECURA3PMA Approval
- P980050TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH)3PMA Approval
- P900061DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-13PMA Approval
- P980016ENTRUST, INSTRINSIC, MARQUIS, SECURA, VARIOUS MODELS OF MAXIMO, PROTECTA, & VIRTUOSO3PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS3PMA Approval
- P980016MAXIMO II/SECURA/VIRTUOSO II3PMA Approval
- P980016MAXIMO II/SECURA/VIRTUOSO II3PMA Approval
- P900061DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-13PMA Approval
- P980050TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH)3PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS3PMA Approval
- P980016MAXIMO II/SECURA/VIRTUOSO II3PMA Approval
- P900061DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-13PMA Approval
- P980016MAXIMO II/SECURA/VIRTUOSO II3PMA Approval
- P980016MAXIMO II/SECURA/VIRTUOSO II3PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS3PMA Approval
- P900061DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-13PMA Approval
- P980016MAXIMO II/SECURA/VIRTUOSO II3PMA Approval
- P980050TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH)3PMA Approval
- P980016MAXIMO II/SECURA/VIRTUOSO II3PMA Approval
- P980016MAXIMO II/SECURA/VIRTUOSO II3PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS3PMA Approval
- P980050TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH)3PMA Approval
- P980016CAPSURE LEAD/ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/II ICDS3PMA Approval
- P900061DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-13PMA Approval
- P980016PROTECTA DR/VR/XT DR/VR ICD3PMA Approval
- P980023KENTROX SL/SL-S/RV/RV-S & LINOX S/SD/T/TD STEROID-ELUTING LEADS3PMA Approval
- P920015IS-1 PORT PIN PLUG/Y ADAPTOR KIT/LEAD ADAPTOR/SPRINT LEAD/QUATTRO/QUATTRO SECURE/SUBCUTANEOUS DEFIBRILLATION/TRANSVENE3PMA Approval
- P980050CS-SVC TRANSVENE LEAD3PMA Approval
- P900061ACE HEADER/PATCH LEAD/LEAD END PIN CAP3PMA Approval
- P980016MARQUIS/MAXIMO ICD/INTRINSIC ICD/CAPSURE LEAD/ENTRUST ICD/VIRTUOSO ICD/MAXIMO II ICD/SECURA ICD/VIRTUOSO II ICD3PMA Approval
- P910077LATITUDE PACEART INTEGRATION3PMA Approval
- P910073ENDOTAK/ ENDOTAK RELIANCE/ENDOTAK ENDURANCE LEADS3PMA Approval
- P910077ENDOTAK LEADS3PMA Approval
- P830060TACHY ADAPTER (ACCESSORY)3PMA Approval
- P910073RELIANCE IS-1 FAMILY OF LEADS3PMA Approval
- P920015TRANSVENE SVC LEAD3PMA Approval
- P980016PROTECTA DR/VR/XT DR/VR ICD3PMA Approval
- P900061EPICARDIAL LEADS AND ACCESSORIES3PMA Approval
- P980016ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/II/II M4/PROTECTA/XT/PROTECT XT M4/PROTECTA M4/SECURA/SECURA M4/VIRTUOSO/II ICDS3PMA Approval
- P980016SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/MAXIMO/INTRINSIC/PROTECTA/PROTECTA XT3PMA Approval
- P910073ENDOTAK RELIANCE TACHY LEAD3PMA Approval
- P980016SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/PROTECTA DR/VR/PTOTECTA XT DR/VR/INSYNC II/III MARQUIS3PMA Approval
- P980016PROTECTA + PROTECTA XT3PMA Approval
- P980023LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS3PMA Approval
- P980016PROTECTA DR/VR/PROTECTA XT DR/VR3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980016ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II3PMA Approval
- P920015Y ADAPTOR/EXTENDER KIT/DF-1 CONNECTOR PORT PIN PLUG/ LEAD ADAPTOR/SPRINT/SPRINT QUATTRO/QUATTRO LEAD/SUBCUTANEOUS LEAD3PMA Approval
- P900061ACCESSORY (UPSIZING SLEEVE) ACE/ACE 5434T/ACE HEADER/LEAD END PIN CAP3PMA Approval
- P910077VENTAK PRX AICD SYSTEM3PMA Approval
- P980016PROTECTA DR/VR/XT DR/VR3PMA Approval
- P980016PROTECTA DR/VR/XT DR/VR3PMA Approval
- P980016VIRTUOSO II/SECURA/MAXIMO II ICDS3PMA Approval
- P900061ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P920015SUBCUTANEOUS LEAD SYSTEM, TRANSVENE SVC LEAD3PMA Approval
- P920015TRANSVENE SVC LEAD MODEL 6937/SUBCUTANEOUS LEAD MODEL 6996SQ & VARIOUS ACCESSORIES3PMA Approval
- P900061TRANSVENE EPICARDIAL LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P950022RIATA/RIATA ST/RIATA ST OPTIM/DURATA3PMA Approval
- P980016PROTECTA DR/VR/XT DR/VR3PMA Approval
- P980016PROTECTA DR/VR/XT DR/VR3PMA Approval
- P980016PROTECTA DR/VR/XT DR/XT VR3PMA Approval
- P980016PROTECTA DR/VR/XT DR/XT VR3PMA Approval
- P910073RELIANCE LEADS3PMA Approval
- P830060VENTAK/VENTAK P/VENTAK P2 FAMILIES3PMA Approval
- P910073ENDOTAK RELIANCE3PMA Approval
- P940008RES-Q/RES-Q MICRON FAMILIES3PMA Approval
- P910077VENTAK PRX/MINI FAMILIES3PMA Approval
- P930035VENTAK/VENTAK P/VENTAK P2 FAMILIES3PMA Approval
- P890061VENTAK/VENTAK P/VENTAK P2 FAMILIES3PMA Approval
- P910073ENDOTAK FAMILY3PMA Approval
- P910077LATITUDE COMMUNICATORS3PMA Approval
- P980016SECURA DR/VR, VIRTUOSO II DR/VR, MAXIMO II DR/VR ICDS3PMA Approval
- P980016MAXIMO II/SECURA/VIRTUOSO II ICDS3PMA Approval
- P900061ACCESSORY-UPSIZING SLEEVE/LEAD END PIN CAP3PMA Approval
- P920015SPRINT QUATTRO/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD3PMA Approval
- P980050TRANSVENE CS/SVC3PMA Approval
- P980016MEDTRONIC PROTECTA XT DR D314DRG, PROTECTA XT VR D314VRG, PROTECTA DR D334DRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS3PMA Approval
- P980016MAXIMO II, SECURA AND VIRTUOSO II3PMA Approval
- P980016SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS3PMA Approval
- P980016MARQUIS/MAXIMO3PMA Approval
- P980016SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO ICDS3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICDS3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS3PMA Approval
- P980023LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS3PMA Approval
- P980016ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/SECURA/VIRTUOSO/VIRTUOSO II3PMA Approval
- P980016ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II DR/II VR/SECURA DR/VR/VIRTUOSO/II DR/II VR3PMA Approval
- P980016MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR/VIRTUOSO/ENTRUST/MARQUIS/MAXIMO/INTRINSIC ICDS3PMA Approval
- P910073RELIANCE 4-SITE3PMA Approval
- P980016VIRTUOSO II/SECURA/MAXIMO II ICDS3PMA Approval
- P980016VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR ICDS3PMA Approval
- P950022DURATA FAMILY OF LEADS3PMA Approval
- P980016VIRTUOSO II/SECURA/MAXIMO II ICDS3PMA Approval
- P980016VIRTUOSO II/SECURA/MAXIMO II ICDS3PMA Approval
- P980016SECURA DRVR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS3PMA Approval
- P920015SPRINT QUATTRO3PMA Approval
- P980016GEM II/MARQUIS/MAXIMO/II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/SECURA DR/VR ICDS3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR3PMA Approval
- P910073RELIANCE IS -1 AND RELIANCE IS-43PMA Approval
- P980016MARQUIS/MAXIMO3PMA Approval
- P900061ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR3PMA Approval
- P920015LEAD ADAPTOR/IS-1 CONNECTOR PORT PIN PLUG KIT/Y ADAPTOR/EXTENDER KIT/SPRINT LEAD DRUG COMBINATION/TRANSVENE DF1/RV LEAD3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980016CAPSURE LEAD DRUG COMBINATION/MARQUIS/MAXIMO/INTRINSIC30/INTRINSIC/ENTRUST/VIRTUOSO/SECURA/VIRTUOSO II/MAXIMO II ICDS3PMA Approval
- P980016MARQUIS/MAXIMO3PMA Approval
- P900061ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ACCESSORY (UPSIZING SLEEVE)3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980016CAPSURE LEAD DRUG COMBINATION/MARQUIS/MAXIMO/INTRINSIC3/INTRINSIC/ENTRUST/VIRTUOSO/SECURA/VIRTUOSO II/MAXIMO II ICDS3PMA Approval
- P920015SPRINT LEAD/TRANSVENE DF1/RV LEAD/SPRINT QUATTRO/TRANSVENE SVC/CS/SUBCUTANEOUS/TUNNELING TOOL/TRANSVENE SUBQ LEADS3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481 SOFTWARE, VERSION 1.6.3PMA Approval
- P920015SPRINT QUATTRO LEADS MODELS 6935/69473PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD3PMA Approval
- P920015SPRINT QUATTRO SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD3PMA Approval
- P980016CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II3PMA Approval
- P920015IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE CS/SVC/DF1/RV/SUBQ/SVC3PMA Approval
- P900061ACCESSORY (UPSIZING SLEEVE)/UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP/MICRO JEWEL/II/TRANSVENE DEFIBR3PMA Approval
- P980050JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD3PMA Approval
- P830060LEAD TUNNELER MODEL 68883PMA Approval
- P920015SPRINT QUATTRO3PMA Approval
- P980016SECURA, VIRTUOSO II & MAXIMO II3PMA Approval
- P980016ENRYTHM IPG3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD3PMA Approval
- P980016MARQUIS/MAXIMO/INTRINSIC ICDS3PMA Approval
- P910077LATITUDE COMMUNICATORS & PROGRAMMER3PMA Approval
- P010031VIRTUOSO, VIRTUOSO 2, SECURA AND MAXIMO 23PMA Approval
- P980016CONCERTO, CONCERTO2 CONSULTA AND MAXIMO 23PMA Approval
- P910073RELIANCE LEADS3PMA Approval
- P980023LINOX SMART STEROID-ELUTING DUAL-COIL ICD LEADS3PMA Approval
- P910077VENTAK PRX AICD SYSTEM3PMA Approval
- P910073RELIANCE ENDOTAK IMPLANTABLE LEADS3PMA Approval
- P980016GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR SECURA DR/VR ICDS3PMA Approval
- P980016VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS3PMA Approval
- P920015IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT QUATTRO/QUATTRO SECURE/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE SVC LEAD3PMA Approval
- P910077VENTAK PRX & VENTAK MINI I-IV3PMA Approval
- P980050CS-SVC TRANSVENE LEAD3PMA Approval
- P920015LEAD & Y ADAPTOR/TUNNELING TOOL/TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT3PMA Approval
- P980050JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD/INCHECK PATIENT ASSISTANT3PMA Approval
- P900061ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP3PMA Approval
- P900061ACCESSORY (UPSIZING SLEEVE)/ LEAD END PIN CAP3PMA Approval
- P920015TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT3PMA Approval
- P980050CS-SVC TRANSVENE LEAD3PMA Approval
- P980016CAPSURE FIX LEAD/MAXIMO/MARQUIS/INTRINSIC/ENTRUST/VIRTUOSO3PMA Approval
- P900061ACE HEADER/TRANSVENE DEFIBRILLATION LEAD/LEAD END PIN CAP/UPSIZING SLEEVE3PMA Approval
- P980016CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II3PMA Approval
- P910073BSC CRV ENDOTAK LEADS3PMA Approval
- P920015SPRINT QUATTRO3PMA Approval
- P980023KAINOX VCS, LINOX S/T/SD/TD, KENTROX SL-S/RV-S/SL/RV STEROID, LINOX(SMART) ST/TD LEADS3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO ICDS3PMA Approval
- P980016MAXIMO II/SECURA/VIRTUOSO/VIRTUOSO II3PMA Approval
- P900061TRANSVENE DEFRIBRILLAITON LEAD3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS3PMA Approval
- P910077IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR VIRTUOSO ICDS3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/ENTRUST/VIRTUOSO3PMA Approval
- P980016SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS3PMA Approval
- P900061ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN3PMA Approval
- P980050JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD3PMA Approval
- P980016ENTRUST3PMA Approval
- P980016ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR SECURA DR/VR ICDS3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR ICDS3PMA Approval
- P980016SECURA VR/MAXIMO II VR/VIRTUOSO II VR3PMA Approval
- P980016SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS3PMA Approval
- P980016GEM/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/SECURA DR/VR3PMA Approval
- P910073RELIANCE LEADS3PMA Approval
- P910077MODEL 3120 ZOOM LATITUDE PROGRAMMER3PMA Approval
- P980023LINOX SD AND LINOX S FAMILY OF ICD PACING LEADS3PMA Approval
- P980016ENTRUST/VIRTUOSO/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS3PMA Approval
- P980016MEDTRONIC SECURA DR/VR D224DRG/ D224VRC, MAXIMO DR/VR D284DRG/ D284VRC, VIRTUOSO II DR/VR D274DRG/ D274VRC3PMA Approval
- P980016RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS3PMA Approval
- P900061EPICARDIAL PATCH LEAD & SIZING/UPSIZING SLEEVE3PMA Approval
- P980050CSS-SVC TRANSVENE LEAD3PMA Approval
- P980016ENTRUST/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VIRTUOSO/VIRTUOSO II VR ICDS3PMA Approval
- P900061ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN3PMA Approval
- P980016CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II3PMA Approval
- P920015IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/FIDELIS/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q DEFIBRILLAION LEAD/TRANSVENE CS/SVC LEAD3PMA Approval
- P980050JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM3PMA Approval
- P910077LATITUDE¿ COMMUNICATOR RF3PMA Approval
- P980050MEDTRONIC AT500 DDDRP PACING SYSTEM3PMA Approval
- P980016MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS3PMA Approval
- P980016GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR3PMA Approval
- P980016CAPSURE FIX LEAD3PMA Approval
- P980050CS-SVC TRANSVENE LEAD3PMA Approval
- P920015LEAD ADAPTOR, IS-1 PORT PIN PLUG, SPRINT, SPRINT FIDELIS, QUATTRO, QUATTRO SECURE & SUBCUTANEOUS DEFIBRILLATION LEADS3PMA Approval
- P900061LEAD END PIN, ACTIVE CAN EMULATOR HEADER, SIZING & UPSIZING SLEEVE3PMA Approval
- P980016SECURA DR/VR/ MAXIMO II DR/VR/VIRTUOSO II DR/VR3PMA Approval
- P980023LINOX SD & LINOX S3PMA Approval
- P980016MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR3PMA Approval
- P980016ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/SECURA/VIRTUOSO/VIRTUOSO II ICDS3PMA Approval
- P980016VIRTUOSO ICD3PMA Approval
- P980016GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS3PMA Approval
- P920015SPRINT/SPRINT QUATTRO/SPRINT QUATTRO SECURE LEAD/TRANSVENE SVC/DF-1 LEADS/SPRINT QUATTRO SINGLE COIL/END CAP ACCESSORY3PMA Approval
- P980050CSS-SVC TRANSVENE LEAD3PMA Approval
- P900061EPICARDIAL PATCH LEAD & SIZING/UPSIZING SLEEVE3PMA Approval
- P980016CAPSUREFIX LEAD/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO FAMILY OF ICDS3PMA Approval
- P980016MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO3PMA Approval
- P980016VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II VR/DR3PMA Approval
- P950022RIATA/RIATA ST/RIATA ST OPTIM/DURATA LEADS3PMA Approval
- P980016MARQUIS IDC FAMILY, MAXIMO ICD FAMILY, INTRINSIC ICD FAMILY, ENTRUST ICD FAMILY3PMA Approval
- P910077VENTAK/PRX/VENTAK MINI I-IV3PMA Approval
- P910073ENDOTAK3PMA Approval
- P830060VENTAK3PMA Approval
- P890061VENTAK P3PMA Approval
- P930035VENTAK P23PMA Approval
- P940008RES-Q/RES-Q MICRON3PMA Approval
- P980016SECURA/DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR3PMA Approval
- P930035#2 BI-DIRETIONAL TORQUE WRENCH3PMA Approval
- P890061SUPERIOR VENA CAVA LEAD3PMA Approval
- P910077ENDOTAK SQ PATCH LEAD/SQ ARRAY LEAD/SQ ARRAY XP/SMALL & LARGE PATCH LEADVENTAK NINI III/IV/ AICD PULSE GENERATORS3PMA Approval
- P910073ENDOTAK RELIANCE/S/ENDOTAK ENDURANCE EZ/ENDOTAK RELIANCE SG/G3PMA Approval
- P940008LEAD CAP ACCESSORY KIT3PMA Approval
- P830060BIFURCATED BIPOLAR ENDOCARDIAL TINED LEAD/BIPOLAR ENDOCARDIAL LEAD/POSITIVE FIXATION PROTECTED HELIX BIPOLAR ENDOCARDIAL3PMA Approval
- P980016GEM II/MARQUIS/MAXIMO/II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO/II DR/VR/SECURA DR/VR ICDS3PMA Approval
- P980016MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS3PMA Approval
- P980016MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR3PMA Approval
- P980016SECURA DR/VR/VIRTUOSO DR/VR ICD/MAXIMO II DR/VR/VIRTUOSO II VR/DR3PMA Approval
- P980016GEM II/MARQUIS/MAXIMO/MAXIMO II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO/VIRTUOSO II DR/VR/SECURA DR/VR3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM3PMA Approval
- P910077MODEL 6476 G2 RF LATITUDE COMMUNICATOR3PMA Approval
- P980016CAPSURE FIX LEADS3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P980016SECURA/VIRTUOSO II/MAXIMO II ICDS3PMA Approval
- P910077IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS3PMA Approval
- P920015SPRINT FIDELIS & QUATTRO3PMA Approval
- P980016VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II DR/VR3PMA Approval
- P980016MAXIMO II ICD/SECURA ICD/VIRTUOSO II ICD3PMA Approval
- P980016MARQUIS/MAXIMO/INSTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS3PMA Approval
- P980016MARQUIS DR/VR/MAXIMO DR/VR/INTRINSIC ICDS3PMA Approval
- P950022DURATA, RIATA, RIATA ST, AND RIATA ST OPTIM FAMILY OF LEADS3PMA Approval
- P950022RIATA/RIATA ST & DURATA FAMILIES OF LEADS3PMA Approval
- P910073RELIANCE LEADS3PMA Approval
- P980016VIRTUOSO/VIRTUOSO II/SECURA/MAXIMO II ICDS3PMA Approval
- P980016MARQUIS VR/DR ICD3PMA Approval
- P980016VIRTUOSO II DR/VR, SECURA DR.VR, MAXIMO II DR/VR3PMA Approval
- P980016MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA ICD FAMILIES3PMA Approval
- P980016MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA/VIRTUOSO II ICDS3PMA Approval
- P980050MODEL 2090 MEDTRONIC CARELINK PROGRAMMER3PMA Approval
- P980016MODEL 2090 MEDTRONIC CARELINK PROGRAMMER3PMA Approval
- P900061LEAD END CAP KIT / LEAD ADAPTOR SLEEVE KIT / UPSIZING SLEEVE KIT3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM3PMA Approval
- P980016GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS/MAXIMO II CRT-D/SECURA FAMILY ICD3PMA Approval
- P950022RIATA/RIATA ST/DURATA LEADS3PMA Approval
- P910077MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM3PMA Approval
- P950022DURATA/RIATA ST OPTIM/RIATA ST FAMILY OF LEADS3PMA Approval
- P980016ENTRUST ICD3PMA Approval
- P980016MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA/VIRTUOSO II FAMILIES OF ICDS3PMA Approval
- P950022SJM DURATA, RIATA ST OPTIM & RIATA ST FAMILIES OF DEFIBRILLATION LEADS3PMA Approval
- P980016MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/VIRTUOSO II/MAXIMO II/SECURA FAMILIES OF ICDS3PMA Approval
- P910073ENDOTAK RELIANCE TACHY LEAD3PMA Approval
- P900061LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P980016CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS3PMA Approval
- P920015VARIOUS FAMILIES OF PACEMAKERS/ DEFIBRILLATORS/ CRTS3PMA Approval
- P980016SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR3PMA Approval
- P950022RIATA ST OPTIM/DURATA LEADS3PMA Approval
- P980016VIRTUOSO/VIRTUOSO II DR/VR ICD/SECURA DR/VR ICD/MAXIMO II DR/VR ICD3PMA Approval
- P920015SPRINT QUATTRO, SPRINT QUATTRO SECURE MODELS 6947 AND 69353PMA Approval
- P910077LATITUDE INDUCTIVE COMMUNICATOR3PMA Approval
- P910077LATTITUDE INDUCTIVE COMMUNICATOR3PMA Approval
- P980016SECURA MAXIMO II, VIRTUOSO DR/VR II FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)3PMA Approval
- P980016MAXIMO VR/DR/MARQUIS VR/DR/INTRINSIC/VIRTUOSO/ENTRUST/SECURA DR/VR/MAXIMO II DR/VR3PMA Approval
- P980016CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS3PMA Approval
- P980016ENTRUST/VIRTUOSO/MAXIMO II/SECURA/MARQUIS/MAXIMO/INTRINSIC 35J/30/VIRTUOSO II ICDS3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P980016VIRTUOSO ICD3PMA Approval
- P980016VIRTUOSO ICD/VIRTUOSO II ICD/SECURA ICD/MAXIMO II ICD3PMA Approval
- P980016ENTRUST/VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR3PMA Approval
- P980016VIRTUOSO ICDS3PMA Approval
- P980016SECURA ICD/MAXIMO II ICD/VIRTUOSO II DR/VR3PMA Approval
- P980023PROGRAMMER SOFTWARE (ICS 3000 802.U/2)3PMA Approval
- P980016SECURA DR/VR MAXIMO II DR/VR AND VIRTUOSO II DR/VR3PMA Approval
- P950022RIATA & DURATA FAMILY OF LEADS3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P980016ENTRUST ICDS3PMA Approval
- P980016SECURA DR/VR, VIRTUOSO II DR/VR AND MAXIMO II DR/VR3PMA Approval
- P980016VIRTUOSO3PMA Approval
- P980050TRANSVENE CS/SVC LEAD3PMA Approval
- P920015SPRINT & SPRINT QUATTRO & SPRINT QUATTRO SECURE3PMA Approval
- P980016CAPSURE FIX3PMA Approval
- P950022RIATA ST OPTIM & DURATA LEADS3PMA Approval
- P950022RIATA/RIATA ST & DURATA FAMILIES OF LEADS3PMA Approval
- P980016VIRTUOSO ICD3PMA Approval
- P980016ENTRUST DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P980016ENTRUST/VIRTUOSO/VIRTUOSO II/MAXIMO/MAXIMO II/SECURA/MARQUIS/INSTRINSIC 35J ICDS3PMA Approval
- P900061LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT3PMA Approval
- P900061EPICARDIAL TRANSVENE/CABLE/ACE HEADER/UPSIZING SLEEVE FOR HV LEAD DF-1/UPSIZING SLEEVE/LEAD END PIN CAP3PMA Approval
- P980016MARQUIS ICD/MAXIMO/MAXIMO II/INTRINSIC/ENTRUST/VIRTUOSO/SECURA ICD FAMILIES3PMA Approval
- P920015LEAD/Y ADAPTORS/IS-1 PORT PIN PLUG/SPRINT LEAD/QUATTRO/QUATTRO SECURE/QUATTRO SINGLE COIL/TRANSVENE SVC/DF-1/Y ADAPTOR3PMA Approval
- P980016CAPSURE FIX LEAD3PMA Approval
- P980050CS-SVC TRANSVENE LEAD3PMA Approval
- P980016VARIOUS FAMILIS OF ICDS3PMA Approval
- P980023LINOX SD 60/16 STEROID-ELUTING, ACTIVE FIXATION ICD LEAD3PMA Approval
- P980016MARQUIS DR/VR/MAXIMO DR/VR/INTRINSIC/ENTRUST/VIRTUOSO ICDS3PMA Approval
- P980016MARQUIS/MAXIMO& MAXIMO II IPG/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/ONYX/VIRTUOSO FAMILY OF ICDS/SECURA ICD3PMA Approval
- P980016GEM, ENTRUST, MARQUIS, MAXIMO, INTRINSIC AND VIRTUSO FAMILIES OF ICDS3PMA Approval
- P980050JEWEL AF, GEMIII AT FAMILY OF ICDS3PMA Approval
- P900061JEWEL AND GEM FAMILIES OF ICDS3PMA Approval
- P980050SVC/CS TRANSVENE LEAD3PMA Approval
- P920015TRANSVENOUS,STEROID ELUTING,QUADRIPOLAR,ACTIVE FIXATION, PACE/SENSE VENTRICULAR LEAD3PMA Approval
- P900061EPICARDIAL TRANSVENE LEAD, CABLE HEADER, ACE HEADER, UPSIZING SLEEVE FOR HV LEAD DF-1, UPSIZING SLEEVE, END CAP3PMA Approval
- P920015SPRINT QUATTRO SECURE LEADS MODELS 6935 & 69473PMA Approval
- P980023CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P980050GEM III AT ICD3PMA Approval
- P900061VARIOUS FAMILIES OF ICDS3PMA Approval
- P910077LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE3PMA Approval
- P920015SPRINT QUATTRO SECURE LEAD3PMA Approval
- P980016VIRTUOSO ICD3PMA Approval
- P980016MAXIMO DR/VR, MARQUIS DR/VR, INTRINSIC ICDS3PMA Approval
- P980016MAXIMO/MARQUIS/INTRINSIC 30/INTRINSIC/ENTRUST3PMA Approval
- P980023CARDIAC AIRBAG AND BELOS FAMILIES OF ICDS3PMA Approval
- P910073RELIANCE FAMILY OF LEADS3PMA Approval
- P910073EASYTRAK 33PMA Approval
- P980016MARQUIS DR/VR 7274/7230 ICD3PMA Approval
- P980016VIRTUOSO II ICD DR/VR3PMA Approval
- P980016VIRTUOSO II ICD DR/VR MODELS3PMA Approval
- P980016SECURA ICD3PMA Approval
- P980016ENTRUST/VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR FAMILIES OF ICDS3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P910073ENDOTAK RELIANCE3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P980016MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT3PMA Approval
- P950022DURATA, RIATA ST OPTIM, RIATA ST, RIATA 8F3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P980050GEM II AT3PMA Approval
- P900061GEM & GEM II VR3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P910077LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE MODELS: 6482 AND 64883PMA Approval
- P980016MAXIMO II DR/VR3PMA Approval
- P980016VIRTUOSO DR/VR/ENTRUST DR/VR/MAXIMO DR/VR/INTRINSIC DR3PMA Approval
- P980016MAXIMO/MAXIMO II DR/VR/MARQUIS/INTRINSIC/ENTRUST/VIRTUOSO3PMA Approval
- P980016VIRTUOSO3PMA Approval
- P980016SECURA DR/VR & MAXIMO II DR/VR3PMA Approval
- P980016VIRTUOSO3PMA Approval
- P920015SPRINT QUATTRO LEAD3PMA Approval
- P980016SECURA DR/VR & MAXIMO II DR/VR3PMA Approval
- P950022RIATA FAMILY OF HIGH VOLTAGE LEADS3PMA Approval
- P980016VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR ICD3PMA Approval
- P910077VENTAK MINI & CONTAK RENEWAL 33PMA Approval
- P980016VIRTUOSO DR/VR3PMA Approval
- P920015VARIOUS FAMILY OF LEADS3PMA Approval
- P900061EPICARDIAL TRANSVENE LEAD AND RELATED ACCESSORIES3PMA Approval
- P980050SVC/CS TRANSVENE LEAD3PMA Approval
- P980016SECURA DR/VR & MAXIMO II DR/VR3PMA Approval
- P980016MEDTRONIC SECURA & MAXIMO II ICDS3PMA Approval
- P980016VIRTUOSO3PMA Approval
- P910073ENDOTAK LEAD ADAPTOR MODEL 69523PMA Approval
- P980016SECURA DR/VR & MAXIMO II DR/VR3PMA Approval
- P910077VENTAK MINI3PMA Approval
- P910077LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE3PMA Approval
- P980016ENTRUST, VISTUOSO, SECURA DR/VR & MAXIMO II DR/VR3PMA Approval
- P950022DURATA, RIATA ST OPTIM, RIATA ST, RIATA SF3PMA Approval
- P980023PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR3PMA Approval
- P980023PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR SYSTEM3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P950022RIATA, RIATA ST, AND DURATA LEADS3PMA Approval
- P980050CS-SVC TRANSVENE LEAD3PMA Approval
- P920015VARIOUS FAMILIES OF LEADS3PMA Approval
- P900061VARIOUS FAMILIES OF ICDS3PMA Approval
- P980016CAPSURE FIX3PMA Approval
- P980016SECURA DR/VR & MAXIMO II DR/VR3PMA Approval
- P910077ZOOM LATITUDE PROGRAMMING SYSTEM3PMA Approval
- P900061MICRO JEWELL II ICD3PMA Approval
- P980050JEWEL AF, GEM III FAMILY OF ICD'S3PMA Approval
- P980016ENTRUST ICD3PMA Approval
- P920015SPRINT LEADS & SPRINT QUATTRO & SECURE LEAD & SPRINT FIDELIS LEADS3PMA Approval
- P920015SVC TRANSVENE LEAD3PMA Approval
- P920015SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 69353PMA Approval
- P920015SPRINT & SPRINT QUATTRO & SPRINT QUATTRO SECURE3PMA Approval
- P980016CAPSURE FIX3PMA Approval
- P980050GEM III3PMA Approval
- P980016GEM DR ICD, GEM II & III FAMILIES, MARQUIS & MAXIMO FAMILES, ONYX, INTRINSIC & ENTRUST & VIRTUOSO FAMILIES OF ICDS3PMA Approval
- P980016VIRTUOSO & ENTRUST3PMA Approval
- P910077LATITUDE PACEART INTEGRATION SYSTEM3PMA Approval
- P980016SECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR3PMA Approval
- P980023LINOX SD, TD & S/T3PMA Approval
- P980016MARQUIS, MAXIMO, INTRINSIC FAMILY, ONYX, VIRTUOSO, ENTRUST FAMILY,3PMA Approval
- P950022DURATA LEADS3PMA Approval
- P980050GEM III AT ICD3PMA Approval
- P980016VARIOUS FAMILES OF ICDS3PMA Approval
- P920015MEDTRONIC SPRINT LEADS3PMA Approval
- P910077VARIOUS ICD FAMILIES & LATITUDE COMMUNICATOR3PMA Approval
- P980016ENTRUST & VIRTUOSO3PMA Approval
- P950022DURATA3PMA Approval
- P980016VIRTUOSO3PMA Approval
- P950022RIATA ST FAMILY OF LEADS3PMA Approval
- P910077VENTAK MINI AICD SYSTEM3PMA Approval
- P950022RIATA FAMILY OF LEADS3PMA Approval
- P910073RELIANCE FAMILY OF LEADS3PMA Approval
- P950022RIATA FAMILY OF LEADS3PMA Approval
- P980016ENTRUST & VIRTUOSO3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P980023CARDIAC AIRBAG (-T) ICDS & BELOS VR (-T) ICDS & TMS 1000 PLUS PROGRAMMING SYSTEM3PMA Approval
- P910077VENTAK MINI & CONTAK RENEWAL 33PMA Approval
- P980016MEDTRONIC ICD'S3PMA Approval
- P980016VIRTUOSO3PMA Approval
- P980050GEM III AT ICD3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P910077LATITUDE INDUCTIVE PATIENT MANAGEMENT COMMUNICATOR3PMA Approval
- P980016MARQUIS, MAXIMO AND EN TRUST DEVICE3PMA Approval
- P910077LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE3PMA Approval
- P950022RIATA FAMILY OF LEADS3PMA Approval
- P910077MODEL 3120 ZOOM PROGRAMMER SYSTEM3PMA Approval
- P910077ZOOM LATITUDE PROGRAMMING SYSTEM3PMA Approval
- P950022RIATA ST OPTIM LEADS AND RIATA STS OPTIM LEADS AND3PMA Approval
- P980016VIRTUOSO3PMA Approval
- P900061CARELINK MONITOR MODELS 2490G, 2490H, 2490J, AND THE 2020A CARDIOSIGHT READER3PMA Approval
- P980016MARQUIS, MAXIMO & ENTRUST ICDS3PMA Approval
- P980016VIRTUOSO FAMILY OF DEVICES3PMA Approval
- P980016VIRTUOSO3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P900061MODEL 2490G/H/J MEDTRONIC CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER3PMA Approval
- P950022RIATA STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 71313PMA Approval
- P910073RELIANCE ACTIVE FIX & RELIANCE PASSIVE FIX STERIOD ELUTING ENDOCARDIAL DEFIBRILLATION LEADS3PMA Approval
- P980016ENTRUST 30J & 35J ICD & VIRTUOSO DR & VR ICD3PMA Approval
- P980016MEDTRONIC ENTRUST 35J ICD (D154ATG, D15DRG. D154VRC) MEDTRONIC VIRTUOSO ICD (D154AWG, D154VWC)3PMA Approval
- P910077VENTAK PRX/MINI ICD SYSTEM3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR3PMA Approval
- P980023LINOX S AND LINOX T ICD LEADS3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P980050VARIOUS FAMILIES OF ICDS3PMA Approval
- P920015MEDTRONIC SPRINT FIDELIS LEAD3PMA Approval
- P980050GEM III AT3PMA Approval
- P980016VARIOUS FAMILIES OF ICD'S3PMA Approval
- P980016VIRTUOSO,MARQUIS,MAXIMO,INTRINSIC & ENTRUST ICDS3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM3PMA Approval
- P980016VARIOUS FAMILIES OF ICD'S3PMA Approval
- P950022TENDRIL & RIATA FAMILY OF LEADS3PMA Approval
- P950022TENDRIL & RIATA FAMILY OF LEADS3PMA Approval
- P980016MEDTRONIC VIRTUOSO ICD (MODELS D154AWG AND D154VWC)3PMA Approval
- P980016VIRTUOSO MODELS D154AWG / D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P900061VARIOUS FAMILIES OF ICD'S3PMA Approval
- P980050JEWEL AF, GEMM III AT FAMILY OF ICD'S3PMA Approval
- P980016VARIOUS FAMILIES OF ICD'S3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR SOFTWARE, VERSION 1.3 (MODEL 6481)3PMA Approval
- P950022RIATA FAMILY OF LEADS3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE3PMA Approval
- P980016VITRTUOSO MODELS D154AWG/D154VWC3PMA Approval
- P950022RIATA ST LEADS3PMA Approval
- P950022RIATA LEAD FAMILY3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM3PMA Approval
- P910077ZOOM LATITUDE PROGRAMMING SYSTEM3PMA Approval
- P980016MEDTRONIC ENTRUST 35J & VIRTUOSO ICDS3PMA Approval
- P910077LATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 64823PMA Approval
- P950022RIATA FAMILY OF LEADS3PMA Approval
- P900061GEM FAMILY OF ICDS3PMA Approval
- P980016SELECTED FAMILIES OF ICDS3PMA Approval
- P980016VIRTUOSO MODELS D154AWG/D154VWC3PMA Approval
- P950022THE RIATA ST FAMILY OF LEADS3PMA Approval
- P980023BIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR3PMA Approval
- P910077VENTAK PRX/ MINI/ CONTAK CD & CD23PMA Approval
- P980023SELECTED MODELS OF SINGLE CHAMBER ICD DEVICES3PMA Approval
- P980023LINOX S & LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS3PMA Approval
- P980016SELECTED FAMILIES OF ICDS3PMA Approval
- P980016VIRTUOSO ICDS3PMA Approval
- P980016ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P950022RIATA LEAD MODELS 1580, 1581 AND 1582; RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES3PMA Approval
- P900061ACTIVE CAN EMULATOR CONNECTOR, TRANSVERSE EPICARDIAL DEFIBRILLATION LEAD, LEAD SLEEVE ADAPTER KIT3PMA Approval
- P920015PIN PLUG, DF-1 Y-ADAPTER/ EXTENDER, LEAD ASSEMBLY SILICONE DEFIBRILLATOR3PMA Approval
- P980023LUMAX FAMILY OF ICDS/CRT-DS3PMA Approval
- P910077MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)3PMA Approval
- P900061VARIOUS FAMILIES OF ICD'S3PMA Approval
- P980016SELECTED FAMILIES OF ICD'S3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P900061GEM FAMILY OF ICDS3PMA Approval
- P980050JEWEL AF, GEM II AT FAMILY OF ICDS3PMA Approval
- P950022RIATA FAMILY OF LEADS3PMA Approval
- P980016MARQUIS DR/VR MODELS 7274,7230B,7230CX,7230E:MAXIMO DR/VR MODELS 7278,7232B,7232CX,7232E INTRINSIC MODELS 7288:ENTRUST D3PMA Approval
- P980016MEDTRONIC VIRTUOSO MODEL D154AWG/ D154VWC IMPLANTABLE DEVICES3PMA Approval
- P920015SPRINT LEADS, TUNNELING TOOLS3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P900061IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) GEM3PMA Approval
- P980050GEM III AT ICD & TRANSVENE LEAD3PMA Approval
- P980016GEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC AND INTRINSIC 30 IMPLANTABLE DEVICES3PMA Approval
- P980016SELECTED FAMILIES OF ICDS3PMA Approval
- P980050MEDTRONIC GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL99743PMA Approval
- P980016CONCERTO MODEL C154DWK IMPLANTABLE DEVICES3PMA Approval
- P980016MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DMA SOFTWARE3PMA Approval
- P980016ENTRUST AND VIRTUOSO ICDS3PMA Approval
- P980016ENTRUST AND VIRTUOSO ICDS3PMA Approval
- P980016ENTRUST AND VIRTUOSO ICDS3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 64813PMA Approval
- P980023VARIOUS MODELS ICD'S TMS 1000 PLUS3PMA Approval
- P910077MODEL 3120 ZOOM LATITUDE PROGRAMMER3PMA Approval
- P980016MARQUIS DR/VR MODELS 7274, 7230B, 7230CX, 7230E3PMA Approval
- P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P980016VIRTUOSO ICD3PMA Approval
- P980023LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS3PMA Approval
- P950022RIATA ST OPTIM LEADS MODELS 7020, 7021,7022,7030,7031,7070 AND 70713PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 64823PMA Approval
- P940008RES-Q3PMA Approval
- P930035VENTAK P23PMA Approval
- P910077VENTAK PR/ VENTAK MINI3PMA Approval
- P910073ENDOTAK3PMA Approval
- P830060VENTAK3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P900061VARIOUS FAMILIES OF ICDS3PMA Approval
- P980050JEWEL AF, GEM III AT FAMILY OF ICDS3PMA Approval
- P980016MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC ICDS, CONCERTO - VERTUOSO V1.0 SOFTWARE -SW002, CONEXUS ACTIVATOR 279013PMA Approval
- P930035VENTAK P23PMA Approval
- P940008RES-Q3PMA Approval
- P830060VENTAK3PMA Approval
- P910073ENDOTAK/ENDURANCE/RELIANCE3PMA Approval
- P910077VENTAK PRX/MINI I-IV3PMA Approval
- P980016SELECTED FAMILIES OF ICD'S, ENTRUST FAMILY,INTRINSIC FAMILY,ONYX, MAXIMO FAMILY, MARQUIS FAMILY,GEM III FAMILY,GEM II FA3PMA Approval
- P900061VARIOUS FAMILIES OF ICD'S, GEM FAMILY, MICRO JEWEL II, MICRO JEWEL, JEWEL AND JEWEL PLUS FAMILY, PCD FAMILY,JEWEL CD 7203PMA Approval
- P910077VENTAK MINI II+ HE, MINI IV, MINI IV+ PULSE GENERATORS3PMA Approval
- P910023EPIC II, EPIC II+, EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILATORS3PMA Approval
- P910073ENDOTAK RELIANCE FAMILY OF LEADS3PMA Approval
- P910077MINI FAMILY OF IMPLANTABLE PACEMAKERS3PMA Approval
- P980023CARDIAC AIRBAG3PMA Approval
- P980016SELECTED FAMILIES OF ICD'S3PMA Approval
- P980050GEM III AT 72763PMA Approval
- P900061GEM FAMILY MODEL 72273PMA Approval
- P910023PHOTON, ATLAS/ATLAS+, EPIC/EPIC+, EPIC 2 ICD'S3PMA Approval
- P980050GEM III AT FAMILY OF ICDS, JEWEL AF3PMA Approval
- P980016VARIOUS FAMILIES OF ICD'S3PMA Approval
- P900061VARIOUS FAMILIES OF ICD'S3PMA Approval
- P910023EPIC/EPIC+ AND ATLAS/ATLAS+ FAMILY OF PULSE GENERATORS3PMA Approval
- P980016MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)3PMA Approval
- P950022RIATA ST PASSIVE LEAD MODELS 7040, 7041, 7042,7050,7051 AND 70523PMA Approval
- P950022RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 70123PMA Approval
- P910023EPIC,EPIC+,ATLAS+, ATLAS, PHOTON MICRO,PHOTON, ICD'S3PMA Approval
- P980016MEDTRONIC EN-TRUST 30J/35J ICD FAMILY3PMA Approval
- P980016ACCELEROMETER TANTALUM CAPACITOR CHANGE3PMA Approval
- P900061GEM MODEL 7227 IMPLANTABLE DEVICE3PMA Approval
- P980016GEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC, INTRINSIC 30 IMPLANTABLE DEVICES3PMA Approval
- P980016MEDTRONIC ENTRUST MODELS D153ATG, D153DRG,D153VRC,D254ATG,D154DRG,D154VRC3PMA Approval
- P980016MARQUIS DR, MARQUIS VR, MAXIMO DR, MAXIMO VR, INTRINSIC 30, INTRINSIC, ENTRUST 30J/35J3PMA Approval
- P920015CAPSUREFIX MODELS 4568, 4067, 5068, 5067, 5568; SUREFIX MODEL 5072; SPRINT MODELS 6945, 6943; SPRINT QUATTRO MODEL 69473PMA Approval
- P980016MAXIMO DR/ VR MODEL 7278 AND 7232 ICD SYSTEMS3PMA Approval
- P980023LINOX SD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS3PMA Approval
- P980016CARELINK MONITORS, MODELS 2490G AND 2490J3PMA Approval
- P910073ENDOTAK RELIANCE G/SG LEADS3PMA Approval
- P980016VARIOUS FAMILIES OF ICDS3PMA Approval
- P900061VARIOUS FAMILIES OF ICD3PMA Approval
- P980050JEWEL AF,GEM III AT FAMILY OF ICDS3PMA Approval
- P910077GUIDANT ZOOM PROGRAMMER3PMA Approval
- P910073ENDOTAK RELIANCE FAMILY OF LEADS3PMA Approval
- P910073RELIANCE LEADS FLUORO RING3PMA Approval
- P910077RENEWAL 3 RF ICDS3PMA Approval
- P920015MEDTRONIC SPRINT FIDELIS LEADS MODELS,6949,6948,6931,69303PMA Approval
- P910073RELIANCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS3PMA Approval
- P910073RELIANCE ACTIVE FIX, & PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD3PMA Approval
- P910073ENDOTAK RELIANCE AND ENDOTAK ENDURANCE3PMA Approval
- P980016MEDTRONIC IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR SYSTEMS ENTRUST ICOS3PMA Approval
- P980016MEDTRONIC MODEL 9996 AND MODEL 99973PMA Approval
- P950022ST.JUDE MEDICAL RIATA/ RIATA I DEFIBRILLATION LEADS3PMA Approval
- P900061MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS3PMA Approval
- P980016MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS3PMA Approval
- P910073RELIANCE LEADS3PMA Approval
- P980016ENTRUST ICD3PMA Approval
- P910073ENDOTAK RELIANCE LEADS3PMA Approval
- P980016MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS3PMA Approval
- P950022EPIC AND ATLAS FAMILIES OF DEVICES3PMA Approval
- P910077LATITUDE PATIENT MANAGEMENT SYSTEM3PMA Approval
- P910073RELIANCE LEADS3PMA Approval
- P980016RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS3PMA Approval
- P910077MODEL 3120 ZOOM LATITUDE PROGRAMMER/ RECORDER/MONITOR, MODEL 3122 ANTENNA ACCESSORY, AND CONSULT PROGRAMMER SOFTWARE...3PMA Approval
- P910073RELIANCE ACTIVE FIX AND PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD3PMA Approval
- P980016MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE3PMA Approval
- P980023KENTROX FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS, RV, SL, RV-S, SLS3PMA Approval
- P910077VENTAK MINI3PMA Approval
- P910073RELIANCE TRANSVENOUS ENDOCARDIAL DEFIBRILLATION LEAD3PMA Approval
- P830060GUIDANT PULSE GENERATORS3PMA Approval
- P980016MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWAR3PMA Approval
- P980016MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR...3PMA Approval
- P950022RIATA ST LEAD MODELS 7000, 7001, AND 70023PMA Approval
- P950022RIATA DEFIBRILLATION LEADS3PMA Approval
- P950022RIATA FAMILY OF DEFIBRILLATION LEADS3PMA Approval
- P950022RIATA FAMILY OF DEFIBRILLATION LEADS3PMA Approval
- P950022RIATA FAMILY OF DEFIBRILLATION LEADS3PMA Approval
- P950022RIATA FAMILY OF DEFIBRILLATION LEADS3PMA Approval
- P980016INSYNC MAXIMO MODEL 7303 ONYX VR3PMA Approval
- P910073ENDOTAK FAMILY INCLUDES ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE3PMA Approval
- P910077HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.13PMA Approval
- P910077MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM3PMA Approval
- P890061VENTAK P3PMA Approval
- P910077VENTAK PRX, VENTAK MINI3PMA Approval
- P910073ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE3PMA Approval
- P830060VENTAK, BIPOLAR ENDOCARDIAL3PMA Approval
- P930035VENTAK P2, VENTAK P33PMA Approval
- P940008RES-Q3PMA Approval
- P830060VENTAK BIPOLAR ENDOCARDIAL3PMA Approval
- P930035VENTAK P33PMA Approval
- P910077VENTAK PRX, VENTAK MINI3PMA Approval
- P910073ENDOTAK,ENDOTAK ENDURANCE, ENDOTAK RELIANCE3PMA Approval
- P890061VENTAK P3PMA Approval
- P940008RES-Q3PMA Approval
- P980023KENTROX RV-S STEROID AND KENTROX SL-2 STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS3PMA Approval
- P980016MARQUIS VR, DR/MAXIMO/ MAXIMO DR/ INTRINSIC 30/INTRINSIC3PMA Approval
- P910073LEAD ADAPTERS MODEL NUMBER 60243PMA Approval
- P980050GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL 99743PMA Approval
- P980016MEDTRONIC MAXIMO VR MODELS 7232B AND 7232 IMPLANTABLE CARDIAC DEFIBRILLATORS (ICDS)3PMA Approval
- P980016MEDTRONIC INTRINSIC MODELS 7287 AND 7288 ICD SYSTEMS3PMA Approval
- P980023KENTROX RV STEROID AND KENTROX SL STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS3PMA Approval
- P830060LEAD ADAPTERS MODEL 6833, 6836, 69313PMA Approval
- P910073LEAD ADAPTERS, MODEL NUMBERS 6833, 6836, AND 69313PMA Approval
- P980016INTRINSIC 30 DUAL CHAMBER INPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM3PMA Approval
- P920015MODEL 6948 AND 6930 LEADS3PMA Approval
- P920015MODEL 6949 AND 6931 LEADS3PMA Approval
- P930035VENTAK P2,VENTAK P33PMA Approval
- P910073ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE3PMA Approval
- P830060VENTAK BIPOLAR ENDOCARDIAL LEADS3PMA Approval
- P910077VENTAK PRX,VENTAK MINI3PMA Approval
- P890061VENTAK P3PMA Approval
- P950022RIATA DEFIBRILLATION LEAD FAMILY3PMA Approval
- P980050MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 99743PMA Approval
- P980016MEDTRONIC MODEL 7278 MAXIMO DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND MODEL 7232 MAXIMO VR SINGLE CHAM3PMA Approval
- P980023KENTROX SL ICD LEADS3PMA Approval
- P980016MEDTRONIC ONYX SYSTEM, DEVICE MODEL 7290CX AND SOFTWARE MODEL 99993PMA Approval
- P910073ENDOTAK RELIANCE G/SG LEAD MODELS 0180-01873PMA Approval
- P910073ENDOTAK/ ENDURANCE/ RELIANCE3PMA Approval
- P910077VENTAK PRX/ MINI III/ MINI IV3PMA Approval
- P830060VENTAK3PMA Approval
- P940008RES-Q3PMA Approval
- P910077VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P980016MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II3PMA Approval
- P910077VENTAK MINI I, II,III3PMA Approval
- P910077VENTAK MINI III,MINI IV3PMA Approval
- P910077VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P830060BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942)3PMA Approval
- P930035HEX WRENCH(MODEL 6501)3PMA Approval
- P980050JEWEL AF 72503PMA Approval
- P980016MEDTRONIC. GEM DR MODEL 7271 D3PMA Approval
- P910073ENDOTAK RELIANCE G AND SG ENDOCARDIAL DEFIBRILLATION LEAD3PMA Approval
- P980023CARDIAC AIRBAG ICD, 345-424, CARDIAC AIRBAG-T ICD, 341-517, A-K00.1.U. PROGRAMMER SOFTWARE, 346-1683PMA Approval
- P980016MEDTRONIC MARQUIS DR 7274.MARQUIS VR 7230,MAXIMO DR 7278,MAXIMO VR 72323PMA Approval
- P980016MEDTRONIC MODEL 7278 MAXIMO DR ICD AND MODEL 7232 MAXIMO VR ICD SYSTEMS, WITH MODEL 9978 VERSION 1.0 APPLICATION SOFTWA3PMA Approval
- P980016MARQUIS VR ICD3PMA Approval
- P920015SPRINT QUATTRO STEROID-ELUTING LEAD MODEL 69443PMA Approval
- P950022ST.JUDE MEDICAL RIATA DEFIBRILLATION LEADS3PMA Approval
- P910073ENDOTAK RELIANCE STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD3PMA Approval
- P980023CARDIAC AIRBAG / CARDIAC AIRBAG-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P980016MEDTRONIC MODEL CAPSUREFIX 69403PMA Approval
- P910023EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P920015SPRINT/SPRINT QUATTRO3PMA Approval
- P980016CAPSURE FIX3PMA Approval
- P950022RIATA DEFIBRILLATION LEAD SYSTEM MODEL 1572 AND 15823PMA Approval
- P910077VENTAK PRX AND MINI ICDS3PMA Approval
- P910023IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A3PMA Approval
- P980016MODEL 7230 MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM3PMA Approval
- P900061MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA)3PMA Approval
- P980016MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA)3PMA Approval
- P900061GEM MODEL 7227 CX/B/D/E3PMA Approval
- P980016GEM III DR 7275, GEM III VR 7231, GEM DR 72713PMA Approval
- P980050GEM III AT 72763PMA Approval
- P910023ST.JUDE MEDICAL EPIC/ATLAS DR/VR ICD3PMA Approval
- P910023APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)3PMA Approval
- P950022RIATA SERIES DEFIBRILLATION LEAD SYSTEM3PMA Approval
- P900061MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) PRODUCT3PMA Approval
- P980016MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS WITH3PMA Approval
- P930035VENTAK P2 LEADS AND ACCESSORIES3PMA Approval
- P830060VENTAK LEADS AND ACCESSORIES3PMA Approval
- P910073ENDOTAK/ENDURANCE/RELIANCE LEADS AND ACCESSORIES3PMA Approval
- P910077VENTAK PRX LEADS AND ACCESSORIES3PMA Approval
- P940008RES-Q ACCESSORIES3PMA Approval
- P910023MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE3PMA Approval
- P910023ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235)3PMA Approval
- P910073ENDOTAK RELIANCE/RELIANCE S STEROID ELUTING EXTENDABLE/RETRACTABLE HELIX ENDOCARDIAL DEFIBRILLATION LEAD3PMA Approval
- P910077VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/3PMA Approval
- P900061MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 72183PMA Approval
- P980016MODEL 2490A CARELINK MONITOR AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE MODEL 2491 VERSION 1.03PMA Approval
- P900061GEM MODEL 7227 ICD3PMA Approval
- P980016MARQUIS DR ICD3PMA Approval
- P980016GEM & MARQUIS FAMILY ICD'S3PMA Approval
- P980050MEDTRONIC JEWEL/GEM ICD'S3PMA Approval
- P900061MEDTRONIC GEM ICD3PMA Approval
- P950022RIATA SERIES 1500 DEFIBRILLATION LEAD SYSTEM3PMA Approval
- P910023PHOTON MICRO MODEL V-194, V-232 AND ATLAS MODEL V-199 , V-240 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P980016MARQUIS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR3PMA Approval
- P980016MODEL 7271 GEM DR, MODEL 7273 GEM II DR, MODEL 7275 GEM III DR ICDS3PMA Approval
- P980050GEM III AT MODEL 72763PMA Approval
- P910073ENDOTAK: DSP, ENDURANCE EZ, AND ENDURANCE RX LEADS3PMA Approval
- P910023ATLAS DR/VR IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR3PMA Approval
- P980016MODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE3PMA Approval
- P980016GEM II FAMILY OF ICD/PULSE GENERATORS3PMA Approval
- P980050GEM III AT MODEL 7276 ICD/PULSE GENERATORS3PMA Approval
- P920015SPRINT FAMILY OF LEADS3PMA Approval
- P900061GEM ICD/IPG3PMA Approval
- P910023IDENTITY SR MODEL 5172 PULSE GENERATOR3PMA Approval
- P900061MEDTRONIC GEM ICD3PMA Approval
- P920015MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD3PMA Approval
- P980050MEDTRONIC JEWEL AF ICD3PMA Approval
- P900061MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD)3PMA Approval
- P910023CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P900061GEM VR MODELS 7227 B/D/E/CX3PMA Approval
- P910023PROFILE MD (MODELS V-186F AND V-186HV3), PHOTON DR (MODEL V-230HV) AND PHOTON U VR/DR IMPLANTABLE CARDIOVERTER3PMA Approval
- P950022TVL LEAD SYSTEM3PMA Approval
- P910023MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE3PMA Approval
- P900061MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) MODEL 5460 ACE HEADER3PMA Approval
- P980050MEDTRONIC MODEL 7250 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (AF ONLY STUDY)3PMA Approval
- P900061MICRO JEWEL/JEWEL II3PMA Approval
- P920015MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT3PMA Approval
- P980050MEDTRONIC MODEL 7250 ARRHYTHMIA MANAGEMENT DEVICE3PMA Approval
- P910023PROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER)3PMA Approval
- P980050MODEL 6943 SPRINT(R) LEAD3PMA Approval
- P920015MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT3PMA Approval
- P910023PHOTON MICRO(U) DR/VR MODELS V-232/V-194 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTW33PMA Approval
- P920015MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL3PMA Approval
- P900061MEDTRONIC GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 72763PMA Approval
- P980050MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 72763PMA Approval
- P980050MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR3PMA Approval
- P900061MICRO JEWEL/JEWEL II3PMA Approval
- P980050JEWEL AF SYSTEM3PMA Approval
- P900061MEDTRONIC VISION SOFTWARE SERIES 4.03PMA Approval
- P910023VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE3PMA Approval
- P980050MEDTRONIC GEM III AT MODEL 7276 (ICD)3PMA Approval
- P970024LYRA(TM) ICD SYSTEMS3PMA Approval
- P920015MEDTRONIC MODEL 6725 PIN-PLUG FOR IS-1 PORT3PMA Approval
- P910077VENTAK MINI IV (AICD)3PMA Approval
- P930035VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 16353PMA Approval
- P910073ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS3PMA Approval
- P950022CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM3PMA Approval
- P910023CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM3PMA Approval
- P920015SPRINT QUATTRO MODEL 6944 LEAD3PMA Approval
- P900061GEM MODEL 7227/MICROJEWEL MODELS 7221, 7223 ICDS3PMA Approval
- P910077VENTAK MINI IV (AICD)3PMA Approval
- P910023VENTRITEX ICD'S3PMA Approval
- P910073RELIANCE/RELIANCE S3PMA Approval
- P910023CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910073ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS3PMA Approval
- P910073ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS3PMA Approval
- P910073IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER3PMA Approval
- P910077ENDOTAK SQUARE ARRAY XP SUBCUTANEOUS LEAD, SQUARE PATCH LEAD, EPICARDIAL PATCHES3PMA Approval
- P890061VENTAK P MODEL 16OO3PMA Approval
- P830060MODEL 6577 STERILIZABLE TELEMETRY WAND3PMA Approval
- P950022TVL LEAD SYSTEM3PMA Approval
- P910073IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER3PMA Approval
- P950022VENTRITEX TUL LEAD SYSTEM3PMA Approval
- P910023CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P950022VENTRITEX(R) TVL(R) LEAD SYSTEM3PMA Approval
- P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF3PMA Approval
- P830060MODEL 6577 STERILIZABLE TELEMETRY WAND3PMA Approval
- P910077MODEL 2920 PRM SYSTEM ZOOM (VENTAK PRX AICD SYSTEM)3PMA Approval
- P910073ENDURANCE EZ ENDOCARDIAL DEFIBRILLATION LEAD3PMA Approval
- P950022VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD3PMA Approval
- P910073ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES3PMA Approval
- P910077ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD, SQ PATCH LEAD, EPICARDIAL PATCHES3PMA Approval
- P830060VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM3PMA Approval
- P910077VENTAK PRX AICD SYSTEM3PMA Approval
- P910073ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM3PMA Approval
- P900061GEM IMPLANTABLE CARDIOVERTER/ DEFIBRILLATOR3PMA Approval
- P830060VENTAK(R) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM3PMA Approval
- P910073ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM3PMA Approval
- P950022VENTRITEX SPL LEAD SYSTEM3PMA Approval
- P830060STYLET ACCESSORY KIT3PMA Approval
- P900061MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM3PMA Approval
- P950022VENTRITEX TVL-ADX ACTIVE-FIXATION STEROID-ELUTING TACHYARRHYTHMIA LEAD3PMA Approval
- P910077DELTA/VISTA PACEMAKERS3PMA Approval
- P910023CADENCE TIERED-THERAPYDEFIBRILLATOR SYSTEM3PMA Approval
- P910073ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS3PMA Approval
- P910023CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P920015MEDTRONIC SPRINT FAMILY OF TRANSVENOUS DEFIBRILLATION LEADS3PMA Approval
- P970024ANGEION SENTINEL(TM) IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(ICD)SYSTEM: REMOVAL OF PATIENT MONITORING REQUIREMENT3PMA Approval
- P980023PHYLAX 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM3PMA Approval
- P910023VENTRITEX HOUSECALL RECEIVER/TRANSMITTER3PMA Approval
- P900061MEDTRONIC MODEL 7227CX GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR3PMA Approval
- P910073ENDOTAK ENDURANCE EZ ENDOCARDIAL DIFIBRILLATION LEAD3PMA Approval
- P910023VENTRITEX CONTOUR II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR3PMA Approval
- P910023VENTRITEX CONTOUR II/MD; ANGSTROM II/MD; PROFILE II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR3PMA Approval
- P980023PHYLAX ICD3PMA Approval
- P900061GEM MODEL 7227 CX ICD3PMA Approval
- P910023CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P950022TVL LEAD SYSTEM3PMA Approval
- P910077VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM3PMA Approval
- P970024LYRA IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR:ANGEPASS DEFIBRILLATION LEAD SYSTEM3PMA Approval
- P910023CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P970024MULTI-PARTITION OPERATING ENVIRONMENT (MOE), VERSION 1.03PMA Approval
- P910023CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910073ENDOTAK ENDURANCE RX ENDOCARDIAL DEFIBRILLATION LEADS3PMA Approval
- P910077MODEL 6960 SWITCHABLE ECG PATIENT CABLE3PMA Approval
- P910023CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P950022TVL LEAD SYSTEM3PMA Approval
- P830060SWEET TIP3PMA Approval
- P910077VENTAK MINI ACID FAMILY SYSTEMS3PMA Approval
- P920015MEDTRONIC SPRINT MODELS 6943/69453PMA Approval
- P830060BIPOLAR ENDOCARDIAL LEAD3PMA Approval
- P910023CADENCE (R) TIERED THERAPY DEFIBRILLAATOR SYSTEM3PMA Approval
- P980023PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM3PMA Approval
- P910077MODEL 6998 IS-1 LEAD PORT PLUG3PMA Approval
- P950022SPL TRIPOLAR, TINED TRANSVENOUS DEFIBRILLATION LEADS3PMA Approval
- P910023CONTOUR(R) II/ANGSTROM(TM) II ICD SYSTEMS3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS3PMA Approval
- P900061MEDTRONIC(R) MODEL 7227CX GEM (TM) IMPLANTABLE CARDIOVERTER3PMA Approval
- P910023VENTRITEK CONTOUR II TIERED THERAPY IMPLANTABLE DEFIBRILLATOR3PMA Approval
- P970024ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM.3PMA Approval
- P910073ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD3PMA Approval
- P920015MODEL 6943 AND 69453PMA Approval
- P910077VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910077VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS3PMA Approval
- P930035VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 16353PMA Approval
- P900061MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK3PMA Approval
- P910073ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910073ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P950022SPL LEAD SYSTEM3PMA Approval
- P920015MODEL 6943 AND 69453PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910077VENTAK PRX AICD SYSTEM3PMA Approval
- P920015MEDTRONIC SPRINT TM MODEL 6942 LEAD3PMA Approval
- P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM3PMA Approval
- P940024GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.3PMA Approval
- P900061MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P900061MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910077VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD3PMA Approval
- P950022TVL(TM) LEAD SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P900061MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK3PMA Approval
- P900061MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK3PMA Approval
- P900061MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P910077VENTAK PRX AICD SYSTEM3PMA Approval
- P900061MODTRONIC(R) MODELS 7219/B/C/D/E AND 7202C/D/E3PMA Approval
- P930035VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 16353PMA Approval
- P910077ABBOTT IMX SA3PMA Approval
- P910073ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD3PMA Approval
- P930035VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 16353PMA Approval
- P910077VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD3PMA Approval
- P890061VENTAK(R) P MODEL 16003PMA Approval
- P830060BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P900061MEDTRONIC MODEL 7223CX MICRO JEWEL II(TM)3PMA Approval
- P900061MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE3PMA Approval
- P900061MEDTRONIC JEWEL CARDIOVERTER DEFIBRILLATOR3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P830060BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P940008RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS3PMA Approval
- P900061MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK3PMA Approval
- P920015MEDTRONIC SPRINT TM MODEL 6932 LEAD3PMA Approval
- P920015MEDTRONIC SPRINT TM MODEL 6932 LEAD3PMA Approval
- P900061MEDTRONIC MODEL 7221 B/C/CX/D/E MICRO JEWEL W/MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 98943PMA Approval
- P910023CADET TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P910077VENTAK PRX AICD, VENTAK PRX II AICD, VENTAK PRX III AICD, VENTAK MINI AICD, VENTAK MINI HC AICD, VENTAK II AICD3PMA Approval
- P930035VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 16353PMA Approval
- P910073ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P950022TVL(TM) LEAD SYSTEM3PMA Approval
- P910023CADET(TM) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P900061MEDTRONIC MODELS 7200B/C/D/E3PMA Approval
- P910077VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P900061JEWEL(TM) MODELS 7219 B/D/E, 7202 B/D/E JEWEL PLUS 7220 B/D/E3PMA Approval
- P920015MEDTRONIC TRANSVENE LEAD SYSTEM3PMA Approval
- P910073ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 00633PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM/MODEL 6952 LEAD EXTENDER3PMA Approval
- P920015MEDTRONIC(R) MODEL 6937 TRANSVENE SVC LEAD3PMA Approval
- P940008RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS3PMA Approval
- P910077VENTAK(R) PRX(R) AICD(TM) SYSTEM FOR PECTORAL REPLACEMENT OF VENTAK PRXIII PULE GENERATOR3PMA Approval
- P920015MEDTRONIC(R) MODEL 6934S TRANSVENE RV LEAD3PMA Approval
- P890061VENTAK(R) P MODEL 16003PMA Approval
- P930035VENTAK(R) P3 AICD(TM) SYSTEM3PMA Approval
- P910077VENTAK(R) PRX (TM) II AICD SYSTEM3PMA Approval
- P910077VENTAK(R) PRX (TM) II AICD SYSTEM3PMA Approval
- P910023CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-15003PMA Approval
- P910077VENTAK MINI AICD SYSTEM3PMA Approval
- P900061MEDTRONIC MODEL 7219B, 7219E, AND 7202E ARRYTHMIA MANAGEMENT DEVICES.3PMA Approval
- P920015MEDTRONIC TRANSVENE LEAD SYSTEM3PMA Approval
- P900061MEDTRONIC MODEL 7219C/7202C JEWEL ACTIVE CAN MANAGEMENT SYSTEMS3PMA Approval
- P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P940008RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P830060VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB3PMA Approval
- P890061VENTAK(R) P MODEL 16003PMA Approval
- P930035VENTAK P2 AICD SYSTEM3PMA Approval
- P910077VENTAK(R) PRX (TM) II AICD SYSTEM3PMA Approval
- P900061MODEL 9881E SOFTWARE (9881E 217214 REVISION:C)3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P830060MODEL 6888 LEAD TUNNELER ACCESSORY3PMA Approval
- P930035VENTAK(R) P3 AICD(TM) SYSTEM3PMA Approval
- P830060MODEL 0010 BIPOLAR ENDOCARDIAL LEAD3PMA Approval
- P900061JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P900061JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P920015MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS.3PMA Approval
- P900061JEWEL ACTIVE CAN & JEWEL PLUS ACTIVE CAN ARRHYTHMIA MGMT SYSTEMS3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEM3PMA Approval
- P910077VENTAK(R) PRX(R) AICD(TM) SYSTEM3PMA Approval
- P900061MODEL 5420 PATIENT CABLE3PMA Approval
- P900061JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P900061JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P930035VENTAK(R) P3 AICD(TM) SYSTEM3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P910077VENTAK(R) PRX II/III AICD SYSTEM AND IS-1/DF-1 LEADS3PMA Approval
- P900061JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P910073ENDOTAK(R) SQ LEAD ARRAY MODEL 00483PMA Approval
- P830060VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P830060VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB3PMA Approval
- P910077VENTAK(R) PRX (TM) II AICD SYSTEM3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P890061VENTAK(R) P MODEL 16003PMA Approval
- P900061JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P930035VENTAK(R) P2 SYSTEM3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P910073ENDOTAK(R) LEAD SYSTEM3PMA Approval
- P910077VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR3PMA Approval
- P830060VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P910073ENDOTAK(R) CLEAD SYSTEM3PMA Approval
- P830060VENTAK MODELS 1550 AND 15553PMA Approval
- P890061VENTAK(R) P MODEL 16003PMA Approval
- P910073ENDOTAK(R) C LEAD, MODELS 0070, 0072,00743PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P900061MODEL 7217D PCD(TM) TACHYARRHYTHMIA CONTROL SYS.3PMA Approval
- P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEM3PMA Approval
- P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEM3PMA Approval
- P910077VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P900061MULTIPROGRAMMABLE TACHYARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P900061MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS.3PMA Approval
- P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEM3PMA Approval
- P900061MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS.3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P900061MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS.3PMA Approval
- P900061MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS.3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P890061VENTAK P MODEL 69103PMA Approval
- P830060VENTAK MODEL 6910 LEAD ADAPTOR3PMA Approval
- P910073ENDOTAK LEAD SYSTEM3PMA Approval
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM3PMA Approval
- P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM3PMA Approval
- P830060ALTERNATE STERILIZATION/VENTAK(TM)1550,55 PULSE3PMA Approval
- P890061VENTAK P MODEL 16003PMA Approval
- P830060VENTAK MODELS 1550 AND 15553PMA Approval
- P890061VENTAK P MODEL 16003PMA Approval
- P830060VENTAK MODELS 1550 AND 15553PMA Approval
- P890061VENTAK P MODELS 1600&1610 & SOFTWARE MODULE 28303PMA Approval
- P830060AID (R) B/BR HIGH VOLTAGE CABLES FOR ECD SYSTEMS3PMA Approval
- P830060MODEL 6866 AICD SPLICE TOOL KIT,6862,63,65,343PMA Approval
- P890061MODEL 6577 STERILIZABLE TELEMETRY WAND3PMA Approval
- P830060MODEL 6577 STERILIZABLE TELEMETRY WAND3PMA Approval
- P830060VENTAK(TM) ECD3PMA Approval
- P830060VENTAK 1550 PULSE GENERATOR3PMA Approval
- P830060MODEL 6837 & 6839 INDUCTION/MONITOR & 6871 O-RINGS3PMA Approval
- P890061VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE3PMA Approval
- P830060AID(R) B/BR3PMA Approval
- P830060CPI SUTURELESS MYOCARDIAL LEAD MODEL 43203PMA Approval
- P830060CPI MODEL 6826 & 6828 AICD LEAD STYLET3PMA Approval
- P830060VENTAK(R) MODEL 1555 PULSE GENERATOR3PMA Approval
- P830060VENTAK(R) MODEL 1555 PULSE GENERATOR3PMA Approval
- P830060VENTAK 1550 PULSE GENERATOR3PMA Approval
- P830060MODEL 6836 Y CONNECTOR (AID B/BR)3PMA Approval
- P830060VENTAK 1550 PULSE GENERATOR3PMA Approval
- P830060AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL3PMA Approval
- P830060MODEL 6577 STERILIZABLE TELEMETRY WAND3PMA Approval
- P830060AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL3PMA Approval
- P830060VENTAK 1550 PULSE GENERATOR3PMA Approval
- P830060AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL3PMA Approval
- P830060AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL3PMA Approval
- P830060AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL3PMA Approval
- P830060AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL3PMA Approval
- P830060AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL3PMA Approval
- P830060AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL3PMA Approval
- P830060AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL3PMA Approval
- P830060AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL3PMA Approval
- P830060VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS3PMA Approval
- LWTOccluder, Balloon, Vena-Cava3Product Code
- LWWPulse-Generator, Single Chamber, Single3Product Code
- LWXDevice. Laser Peripheral Angioplasty3Product Code
- LWZTissue Graft Of Less Than 6mm3Product Code
- LXATissue Graft Of 6mm And Greater3Product Code
- MADCatheter, Percutaneous (Valvuloplasty)3Product Code
- MAEOccluder, Patent Ductus, Arteriosus3Product Code
- MAFStent, Coronary3Product Code
- MCXCatheter, Coronary, Atherectomy3Product Code
- MFADevice, Removal, Pacemaker Electrode, Percutaneous3Product Code
- MGBDevice, Hemostasis, Vascular3Product Code
- MIEHeart-Valve, Allograft3Product Code
- MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment3Product Code
- MIRShunt, Portosystemic, Endoprosthesis3Product Code
- MLVTranscatheter Septal Occluder3Product Code
- MNOSystem, Laser, Transmyocardial Revascularization3Product Code
- MOMSystem, Hemodynamic, Implantable3Product Code
- MOUIntravascular Radiation Delivery System3Product Code
- MRMDefibrillator, Implantable, Dual-Chamber3Product Code
- MTESystem, Pacing, Temporary, Acute, Internal Atrial Defibrillation3Product Code
- MUQGlue, Surgical, Arteries3Product Code
- MVKWearable Automated External Defibrillator3Product Code
- MWGSystem, Oxygen, Aqueous3Product Code
- MWHPulmonic Valved ConduitFProduct Code
- NAPCardiac Support Mesh WrapNProduct Code
- NAVGraft, Bypass, Coronary ArteryFProduct Code
- NGVSystem, Appendage Closure, Left Atrial3Product Code
- NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)3Product Code
- NIMStent, Carotid3Product Code
- NINStent, Renal3Product Code
- NIOStent, Iliac3Product Code
- NIPStent, Superficial Femoral Artery3Product Code
- NIQCoronary Drug-Eluting Stent3Product Code
- NIUStent, Superficial Femoral Artery, Drug-Eluting3Product Code
- NIVCoronary Covered StentFProduct Code
- NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)3Product Code
- NKMMitral Valve Repair Devices3Product Code
- NPTAortic Valve, Prosthesis, Percutaneously Delivered3Product Code
- NPUProsthesis, Mitral Valve, Percutaneously Delivered3Product Code
- NPVPulmonary Valve Prosthesis Percutaneously DeliveredFProduct Code
- NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes3Product Code
- NVYPermanent Defibrillator Electrodes3Product Code
- NVZPulse Generator, Permanent, Implantable3Product Code
- NWXCatheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring3Product Code
- OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter3Product Code
- OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation3Product Code
- OBCOccluder, Internal Vessel, Temporary3Product Code
- OBDBarrier, Adhesion, Cardiovascular3Product Code
- OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation3Product Code
- ODTTissue Adhesive, Aortic AneurysmorrhaphyFProduct Code
- OHAHeart Valve, More Than Minimally Manipulated AllograftUProduct Code
- OJERight Ventricular Bypass (Assist) DeviceFProduct Code
- OJXDrug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode3Product Code
- ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter3Product Code
- OSRPacemaker/Icd/Crt Non-Implanted Components3Product Code
- OZDTemporary Non-Roller Type Left Heart Support Blood Pump3Product Code
- OZGTranscatheter Septal Occluder (Atrial)3Product Code
- OZHTranscatheter Septal Occluder (Ventricular)3Product Code
- PAPAortic Heart Valve, More Than Minimally Manipulated AllograftFProduct Code
- PCWImplantable Pulse Generator, Programmer And Battery ChargerNProduct Code
- PCXArtificial Chordae Tendinae Delivery SystemNProduct Code
- PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment3Product Code
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- PJQAgent, Occluding, Vascular, Permanent3Product Code
- PKKStent Delivery SystemNProduct Code
- PNFAortic Stent3Product Code
- PNYAbsorbable Coronary Drug-Eluting Stent3Product Code
- PRCDrug-Coated Peripheral Transluminal Angioplasty Catheter3Product Code
- PRLIliac Covered Stent, Arterial3Product Code
- QANStent, Iliac Vein3Product Code
- QBIAcute Coronary Syndrome Event Detector3Product Code
- QCTScaffold, Dissection Repair3Product Code
- QFVImplantable Pulse Generator3Product Code
- QLJPatient Monitor With Independent Remote Display And OperationNProduct Code
- QLLLeft Ventricular Ejection Fraction Screening ToolNProduct Code
- QLMIntensive Care Unit, Respiratory Failure And Hemodynamic Instability ToolNProduct Code
- QLNExtracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19NProduct Code
- QMGShockwave Intravascular Lithotripsy System3Product Code
- QNYRemote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation MonitoringNProduct Code
- QNZPowered Communication System For Emergency UseNProduct Code
- QOAPpg Sensor Wearable For Hypercoagulation Detection And Covid-19 ScreeningNProduct Code
- QOCTemporary Non-Roller Type Left Or Right Heart Support Blood PumpNProduct Code
- QIKOrgan Care System (Ocs) Heart System3Product Code
- QSKHybrid Stent Graft, Thoracic Aortic Lesion Treatment3Product Code
- QWACardiovascular Delivery Catheter System Positioning And Stabilization Device1Product Code
- QWMStent Graft, Bypass, Superficial Femoral Artery3Product Code
- QXOCardiovascular Machine Learning-Based Notification Software2Product Code
- QWCPulmonary Stent3Product Code
- QVQExtravascular Support For An Arteriovenous Fistula For Vascular Access3Product Code
- QXVTemperature Regulation Device For Esophageal Protection During Cardiac Ablation2Product Code
- QWNStent Graft, Infrapopliteal, Venous Arterialization3Product Code
- QXUEsophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation2Product Code
- QXXCoronary Artery Disease Machine Learning-Based Notification Software2Product Code
- QYEReduced Ejection Fraction Machine Learning-Based Notification Software2Product Code
- QVGEmbolization Agent, Vascular3Product Code
- QYIAblation Catheter, Renal Denervation3Product Code
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- QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation3Product Code
- QZKEndovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions3Product Code
- QZUTemporary Embolization Assist Device, Peripheral2Product Code
- NPWPercutaneously Delivered Prostheses And Tricuspid Valves3Product Code
- OOBDrug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter3Product Code
- NPSTricuspid Valve Repair Device, Percutaneously Delivered3Product Code
- SATPulmonary Hypertension Machine Learning-Based Notification Software2Product Code
- SBKArtificial Chordae Tendineae Surgical Replacement System2Product Code
- SBQAtrial Fibrillation Risk Prediction Machine Learning-Based Notification Software2Product Code
- QXYOscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification2Product Code
- SCZPercutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures2Product Code
- NXWScaffold, Infrapopliteal, Absorbable3Product Code
- SEGLeadless Cardiac Resynchronization Therapy (Crt)3Product Code
- SEUPeripheral Temporary And Retrievable Stent System2Product Code
- SFRHypertension Machine Learning-Based Notification Software2Product Code
- QKJStent, Central Venous3Product Code
- SEQCovered Stent Vascular Connector, Hemodialysis Access Circuit3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT
- Page Type
- PMA Approval
- Full PDF / Letter* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Boston Scientific Corp.
- Trade Name
- CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
- Generic Name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision Date
- 5/2/2002
- Days to Decision
- 429 days
- Decision Code
- APPR
- FDA Decision
- Approval