Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- 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
- DSTClip, Vena-Cava2Product Code
- DSWBag, Polymeric Mesh, Pacemaker1Product Code
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter2Product Code
- DSZPacemaker Battery3Product Code
- DTATester, Pacemaker Electrode Function2Product Code
- DTBPermanent Pacemaker Electrode3Product Code
- DTCAnalyzer, Pacemaker Generator Function2Product Code
- DTDPacemaker Lead Adaptor2Product Code
- DTEPulse-Generator, Pacemaker, External2Product Code
- DTFTools, Pacemaker Service1Product Code
- DTGMagnet, Test, Pacemaker1Product Code
- DTISizer, Heart-Valve, Prosthesis1Product Code
- DTJHolder, Heart-Valve, Prosthesis1Product Code
- DTKFilter, Intravascular, Cardiovascular2Product Code
- DSPSystem, Balloon, Intra-Aortic And Control2Product Code
- DSRStimulator, Carotid Sinus Nerve3Product Code
- DSSClip, Vascular2Product Code
- DXYImplantable Pacemaker Pulse-Generator3Product Code
- K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A3Cleared 510(K)
- K970072OPUS S MODEL 4121 AND 4124 PACEMAKERS3Cleared 510(K)
- P950029CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKERAPPRPMA Approval
- P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSAPPRPMA Approval
- K945627PIKOS LP 01, PIKOS LP E013Cleared 510(K)
- K954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)3Cleared 510(K)
- K953866MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)3Cleared 510(K)
- K953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS3Cleared 510(K)
- K952328NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E013Cleared 510(K)
- K952364OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)3Cleared 510(K)
- P950037Siello T/JT, Solia T/JT, Siello S, Solia S, Evia DR, Evia DR-T, Evia SR, Entovis DR, Entovis DR-T, Entovis SR, Entovis S3PMA Approval
- P880086Endurity Core, Endurity, Zenex, Zenus3PMA Approval
- P880086Assurity, Assurity+, Endurity, Accent family of Pacemakers3PMA Approval
- P950037Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T (3PMA Approval
- P950029Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot3PMA Approval
- P950037Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, Estella DR,3PMA Approval
- P880086Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL3PMA Approval
- P880086Assurity, Assurity+, Endurity, Accent family of Pacemakers3PMA Approval
- P950029Alizea and Celea Pacemakers3PMA Approval
- P950037Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes3PMA Approval
- P950037Pulse Generator, Permanent, Implantable3PMA Approval
- P950037Pulse Generator, Permanent, Implantable3PMA Approval
- P950037PSW 2100.U and NEO 2100.U3PMA Approval
- P950037Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis SR, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T,3PMA Approval
- P880086Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL and Verity ADx XL3PMA Approval
- P940031VIGOR DR/SR, DISCOVERY, and MERIDIAN3PMA Approval
- P950037Enticos 4 DR, Enticos 4 D, Enticos 4 SR, Enticos 4 S, Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 63PMA Approval
- P950029Reply SR, Reply DR3PMA Approval
- P950037Renamic Neo Programmer3PMA Approval
- P950037Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 83PMA Approval
- P950037Siello S 45 leads and Solia S 45 leads3PMA Approval
- P880086Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL3PMA Approval
- P950037Dromos DR/SR Rate Adaptive Pacing Systems3PMA Approval
- P950037Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 83PMA Approval
- P950037Home Monitoring System Version 3.483PMA Approval
- P880086Assurity, Assurity+, and Endurity3PMA Approval
- P880086Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL3PMA Approval
- P950029Reply SR, Reply DR, Esprit SR, and Esprit DR Pacemakers3PMA Approval
- P950029Reply SR and Reply DR Pacemakers3PMA Approval
- P880086Assurity, Assurity+, Endurity, Accent family of Pacemakers3PMA Approval
- P950037PSW 1904.U3PMA Approval
- P880086Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust3PMA Approval
- P880086Assurity, Endurity Core Family of Pacemakers3PMA Approval
- P950037Pulse Generator, Permanent, Implantable3PMA Approval
- P950037Pulse Generator, Permanent, Implantable3PMA Approval
- P950029Reply SR and Reply DR Pacemakers3PMA Approval
- P950037Pulse Generator, Permanent, Implantable3PMA Approval
- P950029Reply SR and Reply DR Pacemakers3PMA Approval
- P880086Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust3PMA Approval
- P950037Drug Eluting Permanent Right Venticular/Right Atrial Pacemaker Electrodes, Stylets, Stylet, Catheter, Blind Plug, Perman3PMA Approval
- P880086Endurity, Endurity Core, and Assurity pacemakers3PMA Approval
- P880086Endurity, Assurity, and Accent3PMA Approval
- P880086Assurity, Assurity+, Endurity, Accent family of Pacemaker3PMA Approval
- P950037Siello/Solia S Leads Tip3PMA Approval
- P880086Endurity, Endurity Core, Assurity and Assurity +3PMA Approval
- P950037Pulse Generator, Permanent Implantable DR-T/SR-T3PMA Approval
- P950037Pulse Generator, Permanent Implantable, Pulse-Gererator, Pacemaker External, Adapter and Drug Eluting Permanent Right Ve3PMA Approval
- P880086Assurity Pacemaker & Endurity Pacemaker3PMA Approval
- P140033Assurity MRI Pacemakers and Endurity MRI Pacemakers3PMA Approval
- P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS3PMA Approval
- P950029Reply/Esprit (5th generation) Electric Hybrid Module3PMA Approval
- P950037Pulse Generator, Permanent, Inplantable3PMA Approval
- P950037PSW 1901 U3PMA Approval
- P950037Pulse Geneerator, Permanent, Implantable3PMA Approval
- P950037Setrox S 53; Safio S 53; Dextrus 4136;TILDA R53;Solia S 45/53/60, JT 45/53; Siello S53/60/45/53/60/,JT 45/53;3PMA Approval
- P950037Siello S45, S53, S60 and Solia S45, S53, S603PMA Approval
- P940031Accessory Kit3PMA Approval
- P880086Assurity, Assurity+, Endurity, Accent family of Pacemakers3PMA Approval
- P950037PSW 1803.U / HMSC 3.40.2 / CardioMessenger Smart3PMA Approval
- P950037Evia DR/SR; Evia DR-T/SR-T; Entovis DR/SR, Entovis DR-T/SR-T; Estella DR/SR; Estella DR-T/SR-T; Effecta D/S; Edora 8 DR/3PMA Approval
- P140033Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)3PMA Approval
- P950037Pulse Generator, Permanent Implantable, Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Ele3PMA Approval
- P140033Tendril STS 2088TC Lead3PMA Approval
- P880086Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S3PMA Approval
- P880086Quartet, Victory, Zephyr, Accent, Assurity, Assurity+Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL D3PMA Approval
- P950037PSW 1802.U, ACTROS, AXOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, PROTOS, EVIA, ENTOVIS, ECURO, EFFECTA, ESTELLA3PMA Approval
- P950037Siello S 45/53/60, Solia S 45/53/60, Siello T 53/60, Siello JT 45/53, Solia T 53/60, Solia JT 45/53, EFH-6F-W3PMA Approval
- P880086Assurity / Assurity+ / Endurity3PMA Approval
- P950037Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 533PMA Approval
- P950037PSW 1801.U3PMA Approval
- P880086Victory; Zephyr; Accent; Assurity; Assurity+; Endurity; Identity XL, Identity ADx XL; Verity ADxXL3PMA Approval
- P950037Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F3PMA Approval
- P140033Tendril MRI3PMA Approval
- P950037Evia DR,DR-T,SR,SR-T; Entovis DR,DR-T,SR-T; Estella DR,DR-T,SR,SR-T; Effecta D,S; Edora 8 DR, 8 SR; Etrinsa 8 DR-T,SR-T,3PMA Approval
- P140033Assurity MRI and Endurity MRI3PMA Approval
- P880086Assurity, Assurity +, Endurity, Accent and Victory XL3PMA Approval
- P950037Evia DR /DR-T /SR/SR-T ;/Entovis DR /DR-T /SR /SR-T; Estella DR / DR-T/ SR /SR-T; Effecta D /S ;/ Endora 8 DR/ 8 SR; /3PMA Approval
- P950037Siello S 45, Siello S 53, Siello S 60, Solia S 45, Solia S 53, Solia S 603PMA Approval
- P140033Tendril MRI3PMA Approval
- P950029Reply SR, Reply DR, Esprit SR, Esprit DR3PMA Approval
- P880086Assurity, Assurity +, Endurity3PMA Approval
- P140033Endurity MRI, Assurity MRI3PMA Approval
- P880086Assurity, Assurity +, Endurity, Endurity Core3PMA Approval
- P140033Assurity MRI, Endurity MRI3PMA Approval
- P950029Reply SR, Reply DR, Esprit SR, Esprit DR3PMA Approval
- P880086Assurity, Assurity+, Endurity, Accent family of Pacemakers3PMA Approval
- P140033Assurity MRI Endurity MRI family of Pacemakers3PMA Approval
- P140033Tendril MRI Leads (MRI)3PMA Approval
- P140033Tendril3PMA Approval
- P950029Pacemakers Reply SR/DR and Esprit SR/DR3PMA Approval
- P140033Tendril MRI3PMA Approval
- P950029Reply SR / Esprit SR / Reply DR / Esprit DR3PMA Approval
- P140033Assurity MRI, Endurity MRI3PMA Approval
- P880086Assurity, Endurity3PMA Approval
- P140033Assurity MRI, Endurity MRI, Tendril MRI3PMA Approval
- P880086Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx3PMA Approval
- P950037Selox ST/JT; Siello S; Setrox S, Solia S, Safio S3PMA Approval
- P950037Dromos DR/DR-A and Dromos SR/SR-B Cardiac Pacing System3PMA Approval
- P140033Accent MRI Pacemaker3PMA Approval
- P140033Assurity MRI and Endurity MRI3PMA Approval
- P880086Assurity, Assurity+, Endurity, Accent, Identity ADx XL, Sustain XL, Verity ADx XL, Victory XL, and Zephyr XL3PMA Approval
- P950029Reply SR, Reply DR, Esprit SR, Esprit DR3PMA Approval
- P950029REPLY & ESPRIT SR & DR Pacemakers3PMA Approval
- P140033Tendril MRI Cardiac Lead3PMA Approval
- P880086Medical Adhesive3PMA Approval
- P880086Assurity, Assurity+, Endurity3PMA Approval
- P950037Siello, Solia, Setrox, and Safio3PMA Approval
- P140033Low Voltage Active Fixation Lead3PMA Approval
- P950037PSW 1704.U3PMA Approval
- P140033Tendril MRI Leads3PMA Approval
- P140033Tendril MRI3PMA Approval
- P880086Assurity, Assurity+, Endurity, Accent family of Pacemakers3PMA Approval
- P140033Assurity MRI and Endurity MRI family of Pacemakers,3PMA Approval
- P880086Accent, Assurity, Endurity, Verity ADx, Zephyr, Identity ADx, Victory3PMA Approval
- P140033Assurity MRI, Endurity MRI3PMA Approval
- P950037Siello S and Solia S, EFH-6F-W and DH IS-1/DF43PMA Approval
- P140033SJM MRI Activator3PMA Approval
- P880086Assurity, Endurity, Accent, AddVent, Identity, Entity, Paragon III Sustain3PMA Approval
- P880086Assurity, Assurity+, Endurity, Accent family of Pacemakers3PMA Approval
- P140033Assurity MRI PM1272, PM2272; Endurity MRI PM1172, PM21723PMA Approval
- P880086Victory 5816, 5810, 5610; Zephyr 5820, 5826, 5620, 5626; Accent PM1110, PM1210, PM2110, PM2210; Assurity PM1240, PM2240;3PMA Approval
- P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software3PMA Approval
- P140033Endurity MRI ,Assurity MRI Pacemaker3PMA Approval
- P880086Endurity Core, Endurity, Assurity+, Assurity, Sistain, Accent, Zephyr, Victory, Verify ADx XL, Identity Adx, Identity Pa3PMA Approval
- P950037PK-222 and PK-Electrode Clip (accessory to Renamic)3PMA Approval
- P880086Assurity, Assurity+, and Endurity3PMA Approval
- P950029Reply SR, Reply DR, Esprit SR, Esprit DR3PMA Approval
- P950037PSW 1703.U3PMA Approval
- P880086Assurity, Assurity+, Endurity, Accent family of Pacemakers3PMA Approval
- P140033Assurity MRI, Endurity MRI family of Pacemakers3PMA Approval
- P880086Assurity, Assurity+, Endurity families of ICD Devices3PMA Approval
- P950037Setrox S53, S60, Safio S 53, S 60, Solia S 45, S 53, S 60, Siello S 45, S 53, s 60, Blind plug BS IS-13PMA Approval
- P140033Endurity MRI, Assurity MRI3PMA Approval
- P880086Endurity, Endurity Core, Assurity, Assurity+3PMA Approval
- P950029Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation , i.e. V2 ) & (5TH generation i.e.V5)3PMA Approval
- P950037Edora, Evity, Enitra, Enticos 8SR/ SR-T/ DR/ DR-T3PMA Approval
- P950029SMARTVIEW hotspot3PMA Approval
- P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software3PMA Approval
- P950037Siello S 45, S53, S60 / Solia S 45, S53, S 603PMA Approval
- P950037Solia S3PMA Approval
- P950037Edora / Enitra /Enticos / Evity PSW 1701.U3PMA Approval
- P950037Pulse Generator, Permanent Implantable3PMA Approval
- P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software3PMA Approval
- P880086Accent, Identity, Verity, Victory And Zephyr Pacemakers3PMA Approval
- P950037PACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS3PMA Approval
- P950037Pacemaker/ICD/CRT non implanted components PSW 1602.U, HMSC 3.34.03PMA Approval
- P880086Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx3PMA Approval
- P140033Assurity MRI, Endurity MRI, Tendril MRI3PMA Approval
- P950037Edora 8 DR & DR-T, Evity 8 DR-T,Enitra 8 DR-T, Enticos 8 DR-T, Edora 8 SR-T and SR, Evity 8 SR-T, Enitra 8 SR-T,Enticos3PMA Approval
- P140033Tendril MRI leads (MRI)3PMA Approval
- P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software3PMA Approval
- P880086PM1160, PM1240, PM1260, PM2160, PM2240, PM2260, PM1152, PM21523PMA Approval
- P880086AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ ACCENT FAMILY OF PACEMAKERS3PMA Approval
- P140033Tendril MRI3PMA Approval
- P950037PULSE GENERATOR, PERMANENT, IMPLANTABLE3PMA Approval
- P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS3PMA Approval
- P950037PULSE GENERATOR, PERMANENT, IMPLANTABLE3PMA Approval
- P880086ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS3PMA Approval
- P950037Linox smart TD 75/18/ 65/18/ 65/16; Linox smart SD 75/18/ 65/18/ 65/16 60/16; Linox smart T65/ S75/ D65/S60; Linox smart3PMA Approval
- P950029Reply/Esprit Pacemakers Sorin CRM.3PMA Approval
- P950029Repy SR/DR & Esprit SR/DR Pacemakers3PMA Approval
- P950037Reocor S, Reocor D3PMA Approval
- P880086Assurity, Assurity+, Endurity, Endurity Core3PMA Approval
- P950029Reply Sr, Reply DR, Esprit SR, Esprit DR Pacemakers3PMA Approval
- P980049Platinum VR/DR ICDS,Paradym RF VR/ RF DR CRT-Ds, Intensia VR, Intensia DR3PMA Approval
- P060027Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-Ds3PMA Approval
- P880086Assurity - PM1240, PM2240, Assurity+ - PM1260, PM2260, Endurity - PM1160, PM2160, Endurity Core - PM1152, PM21523PMA Approval
- P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS3PMA Approval
- P950037Various models of Evia, Entovis, Estella, Effecta, Ecuro, Eluna, Etrinsa, Epyra Pulse Generator Families3PMA Approval
- P950029REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR Pacemakers3PMA Approval
- P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS3PMA Approval
- P880086Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM3PMA Approval
- P950029Reply SR, Reply DR, Esprit SR, Esprit DR3PMA Approval
- P910023ST.JUDE MEDICAL ICDS/CRT-D3PMA Approval
- P990001VITATRON SOFTWARE MULTIPLE SOFTWARE MODELS3PMA Approval
- P890003CARELINK PROGRAMMER (MODEL 2090)/ANALYZER (MODEL 2290)3PMA Approval
- P950029SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER3PMA Approval
- P880086AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES3PMA Approval
- P880086AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES3PMA Approval
- P980035KAPPA 700/650/600, KAPPA 900/800 AND ENPULSE E1/E23PMA Approval
- P8900032020A CARDIOSIGHT READER AND MODEL 2491 DEVICE DATA MANAGEMENT3PMA Approval
- P890003MEDTRONIC MODEL 2490G CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE3PMA Approval
- P880086PULSE GENERATOR3PMA Approval
- P950037PROTOS DR/CLS AND PROTOS VR/CLS3PMA Approval
- P980035AT500 DDDRP PACING SYSTEM (MODEL AT500) AND MODEL 9968 SOFTWARE POST-MARKET (RESPECT): ADDING THE ENRHYTHM MODEL P1501DR3PMA Approval
- P910023HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-R RECEIVER SOFTWARE (VERSION 2.1)3PMA Approval
- P950037IMPLANT CONTROL SYSTEM (ICS) 30003PMA Approval
- P910023CADENCE (R) TIERED THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P980035MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO3PMA Approval
- P950029SYMPHONY DR 2550 MODE AND ELAVIEW 1.28 UG1 PROGRAMMING SOFTWARE3PMA Approval
- P880086PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,3PMA Approval
- P890003MEDTRONIC MODELS 2490G AND 2490J CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE3PMA Approval
- P990001VITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWA3PMA Approval
- P880086SYCHRONY PULSE GENERATOR3PMA Approval
- P910023EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR3PMA Approval
- P950029ELA MEDICAL RATE-RESPONSIVE PACEMAKERS3PMA Approval
- P890003MEDTRONIC MODEL 2090 CARELINK PROGRAMMER WITH TELEMETRY C3PMA Approval
- P890003CARELINK MONITOR MODELS 2490G, 2490H AND 2490J3PMA Approval
- P910023CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM3PMA Approval
- P910020RELAY3PMA Approval
- P980035KAPPA 700, KAPPA 900, ENPULSE3PMA Approval
- P990001SELECTION AFM, VITATRON C60 DR, C20 SR, T60 DR, AND T20 SR PACING SYSTEMS3PMA Approval
- P880086IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS3PMA Approval
- P910020RELAY3PMA Approval
- P950037SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 533PMA Approval
- P950029SYMPHONY & ELA RHAPSODY PACEMAKERS3PMA Approval
- P8900032490D/E CARELINK MONITORS3PMA Approval
- P890003MODEL 2490G/ 2490H/2490J CARELINK MONITORS FOR USE WITH MODEL 2491 DDMA SOFTWARE3PMA Approval
- P970012MEDTRONIC KAPPA 400 SERIES PACEMAKERS3PMA Approval
- P890003VITATRON LEGACY 11 DR3PMA Approval
- P980035KAPPA 700, 800, 900/SIGMA/ENPULSE3PMA Approval
- P890003MODEL 9879 SOFTWARE FOR THERA/THERA-I/PRODIGY DEVICES, MODEL 9849 SOFTWARE FOR THE LEGACY II/VISA DEVICES, MODEL 9847...3PMA Approval
- P980035MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATIONS SOFTWARE3PMA Approval
- P880086MODEL 3150 PACING SYSTEM ANALYZER WAND AND THE MODEL 3307 V4.7 PROGRAMMER SOFTWARE FOR USE WITH MODEL 3510 PROGRAMMERS3PMA Approval
- P950029SYMPHONY AND ELA RHAPSODY PACEMAKERS3PMA Approval
- P990001VITATRON T60 DR AND T20 SR SYSTEMS3PMA Approval
- P980035AT500 DDDRP PACING SYSTEM3PMA Approval
- P910023HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER AND MODEL 3180-R RECEIVER SOFTWARE (VERS3PMA Approval
- P910023EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T3PMA Approval
- P880086EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR3PMA Approval
- P980035ENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE3PMA Approval
- P950037PHILOS DR-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE3PMA Approval
- P950037PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U3PMA Approval
- P980035MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS3PMA Approval
- P890003MEDTRONIC MODEL 2490D CARELINK MONITOR3PMA Approval
- P980035MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE3PMA Approval
- P980035MEDTRONIC SIGMA MODELS SS106, SSR306, SC203, SDR203, SD303, SDR303, DR353 AND SVDD3033PMA Approval
- P950029SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3)3PMA Approval
- P880086VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR3PMA Approval
- P8900032490D/E CARELINK MONITORS & MODEL 2491 DDMA SOFTWARE FOR INSYNC MARQUIS & MAXIMO VR/DR CAPABILITY3PMA Approval
- P980035ENPULSE INPLANTABLE PULSE GENERATOR3PMA Approval
- P950037PHILOS DR-T PULSE GENERATOR/ICD BELOS VR-T,DR-T,ICD CARDIAC AIRBAG-T3PMA Approval
- P890003SYNERGYST PULSE II GENERATOR3PMA Approval
- P980035MEDTRONIC KAPPA 700/600 SERIES3PMA Approval
- P970012MEDTRONIC. KAPPA 400 SERIES PACEMAKERS3PMA Approval
- P910023HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER (SOFTWARE VERSION 1.1) AND MODEL 3180-R3PMA Approval
- P880086SYNCHRONY MODEL 2020T PULSE GENERATOR3PMA Approval
- P950029SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM3PMA Approval
- P880086ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE3PMA Approval
- P910023ATLAS+ DR/BR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE3PMA Approval
- P980035MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE3PMA Approval
- P890003SYNERGYST II PULSE GENERATOR3PMA Approval
- P990001VITATRON DA+ C SERIES PULSE GENERATORS3PMA Approval
- P910023ADX PULSE GENERATOR3PMA Approval
- P880086ADX PULSE GENERATOR FIRMWARE ANOMALY CORRECTION3PMA Approval
- P980035MEDTRONIC KAPPA 900/800 PACEMAKER SERIES3PMA Approval
- P950037PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/13PMA Approval
- P980035MEDTRONIC SIGMA PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM3PMA Approval
- P990001MODEL VSA02/VSC02 V9.0 PROGRAMMING SOFTWARE FOR THE DIVA, DEMA, AND SELECTION AFM MODEL 902 PULSE GENERATORS3PMA Approval
- P880086IDENTITY ADX XL DC,& SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC3PMA Approval
- P910023IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC3PMA Approval
- P880086EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P980035AT500DDDRP PACING SYSTEM & MODEL 9968 SOFTWARE3PMA Approval
- P880086IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A3PMA Approval
- P950037CARDIOMESSENGER HOME MONITORING SYSTEM3PMA Approval
- P980035MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA)3PMA Approval
- P970012KAPPA 4003PMA Approval
- P990001DIVA PLATFORM,DERMA PLATFORM3PMA Approval
- P980035KAPPA 700/600, 900/800, SIGMA/MEDTRONIC 3503PMA Approval
- P880086APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)3PMA Approval
- P950037PROTOS FAMILY OF PULSE GENERATORS3PMA Approval
- P950029TALENT II DUAL-SENSOR IMPLANTABLE CARDIAC PACEMAKERS, MODELS DR233 AND SR1333PMA Approval
- P950037PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE3PMA Approval
- P880086MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE3PMA Approval
- P880086ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235)3PMA Approval
- P890003MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 72183PMA Approval
- P980035MEDTRONIC KAPPA 700 SERIES OF IPGS3PMA Approval
- P980035MEDTRONIC KAPPA 700 SERIES PULSE GENERATOR PRODUCT FAMILY3PMA Approval
- P980035MEDTRONIC KAPPA 700/600/800/900 PULSE GENERATORS3PMA Approval
- P930022LEGEND PLUS PACEMAKER FAMILY3PMA Approval
- P970012KAPPA 400 PACEMAKER FAMILY3PMA Approval
- P980035MEDTRONIC KAPPA/SIGMA PACEMAKER FAMILIES3PMA Approval
- P990001DEMA/DIVA IMPLANTABLE PULSE GENERATORS3PMA Approval
- P890003MEDTRONIC/VITATRON CARELINK PROGRAMMER3PMA Approval
- P890003MEDTRONIC PACING LEADS3PMA Approval
- P980035MEDTRONIC KAPPA 900/800 SERIES PLUSE GENERATORS3PMA Approval
- P990001PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS3PMA Approval
- P980035KAPPA 900/800 IMPLANTABLE PULSE GENERATOR FAMILY SERIES3PMA Approval
- P890003THERA/THERA-I3PMA Approval
- P980035MEDTRONIC SIGMA AND MEDTRONIC 350 SERIES PULSE GENERATORS3PMA Approval
- P880086ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM3PMA Approval
- P980035MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM3PMA Approval
- P890003THERA/THERA-I FAMILY OF PULSE GENERATORS3PMA Approval
- P980035KAPPA 700/600, SIGMA AND 350 SERIES FAMILIES OF PULSE GENERATORS3PMA Approval
- P970012KAPPA 4003PMA Approval
- P990001DEMA/DIVA IMPLANTABLE PULSE GENERATORS3PMA Approval
- P880086IDENTITY XL DR MODEL 5376 PULSE GENERATOR3PMA Approval
- P950029TALENT AND BRIO PACEMAKERS3PMA Approval
- P980035MEDTRONIC KAPPA 700/600 PULSE GENERATOR3PMA Approval
- P990001DEMA/DIVA IMPLANTABLE PULSE GENERATORS3PMA Approval
- P970012KAPPA 400 IMPLANTABLE PULSE GENERATOR3PMA Approval
- P880086INTEGRITY AFX DR MODEL 53463PMA Approval
- P880086MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE3PMA Approval
- P890003MEDTRONIC PACING LEADS3PMA Approval
- P880086INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A3PMA Approval
- P950029TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG3PMA Approval
- P890003MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) WITH UPDATED TO THE APPLICATION SOFTWARE (MODEL 09-9 SERIES 2.0)3PMA Approval
- P8900039767/9767L PROGRAMMING HEAD AND MODEL9990 DESKTOP SOFTWARE3PMA Approval
- P970012MEDTRONIC KAPPA 400 PACING SYSTEM WITH MODEL 9952 VISION - SERIOE 1.3 SOFTWARE3PMA Approval
- P990001DEMA, DIVA AND AFM PULSE GENERATORS3PMA Approval
- P880086VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE3PMA Approval
- P950029BRIO, TALENT, AND OPUS PACEMAKERS AND PROGRAMMER SOFTWARE3PMA Approval
- P990001VITATRON DIVA PLATFORM3PMA Approval
- P880086INTEGRITY U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS3PMA Approval
- P880086VENTRITEX ICD'S3PMA Approval
- P880086AFFINITY FAMILY OF PULSE GENERATORS3PMA Approval
- P990001VITATRON(R) DEMA PACING SYSTEM3PMA Approval
- P950029ELA RATE-RESPONSIVE PACEMAKERS3PMA Approval
- P950029TALENT AND BRIO PACEMAKERS (RIGID CONNECTOR)3PMA Approval
- P880086INTEGRITY AFX DR/INTEGRITY SR3PMA Approval
- P890003MEDTRONIC 9790/9790C PROGRAMMER3PMA Approval
- P950029ELA RATE-RESPONSIVE PACEMAKERS3PMA Approval
- P880086AV PLUS DX3PMA Approval
- P880086AV PLUS DX MODEL 1368 LEAD3PMA Approval
- P880086AFFINITY PULSE GENERATORS3PMA Approval
- P990001VITATRON DIVA PACING SYSTEM3PMA Approval
- P890003SYNERGYST II PMA FAMILY OF IMPLANTABLE PULSE GENERATORS3PMA Approval
- P880086MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS3PMA Approval
- P880086MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER3PMA Approval
- P950029TALENT MODEL 213 DUAL-CHAMBER, DUAL SENSOR, IMPLANTABLE CARDIAC PACEMAKER, ELA MEDICAL PROGRAMMER3PMA Approval
- P880086INTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS3PMA Approval
- P880086AFFINITY VDR MODEL 5430 PULSE GENERATOR3PMA Approval
- P880086TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO3PMA Approval
- P880006REGENCY SC+, REGENCY SC, REGENCY SCX3PMA Approval
- P8800863500/3510 PROGRAMMER3PMA Approval
- P890003REVEAL PLUS INSERTABLE LOOP RECORDER MODEL 9809 SOFTWARE3PMA Approval
- P970012MEDTRONIC VISION SOFTWARE3PMA Approval
- P950029MULTI-PARTITION OPERATING ENVIRONMENT FOR ELA PROGRAMMERS3PMA Approval
- P910020IMPLANTABLE PACEMAKER LEADS3PMA Approval
- P950029PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG)3PMA Approval
- P990001VITATRON DIVA IMPLANTABLE PULSE GENERATORS3PMA Approval
- P990001VITATRON DIVA3PMA Approval
- P880086TENDRIL/PASSIVE PLUS/AV PLUS DX3PMA Approval
- P880038NETWORK PROGRAMMER3PMA Approval
- P880006SOFTWARE MODEL 3264 REV A3PMA Approval
- P880086CARDIAC PACEMAKER PROGRAMMER & BASE STATION3PMA Approval
- P900070R5.111WE(REVISION OF R5.85WE)3PMA Approval
- P950029BRIO CARDIAC PACEMAKERS3PMA Approval
- P880086POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S3PMA Approval
- P950029BRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE3PMA Approval
- P950037ACTROS+ FAMILY OF PULSE GENERATORS3PMA Approval
- P950037ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U3PMA Approval
- P880086AFFINITY/ENTITY DR,DC,SR3PMA Approval
- P880086ADDVENT/AV PLUS DX3PMA Approval
- P950037ACTROS DR+ -B PULSE GENERATOR3PMA Approval
- P880086ADDVENT MODEL 2060LR PULSE GENERATOR AV PLUS SINGLE PASS LEAD MODEL 1328C3PMA Approval
- P970012MEDTRONIC KAPPA 400 SERIES IPG'S3PMA Approval
- P880086AFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS3PMA Approval
- P880086AFFINITY DR & AFFINITY SR PULSE GENERATORS3PMA Approval
- P950037ACTROS+3PMA Approval
- P950029CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER3PMA Approval
- P950037KAIROS3PMA Approval
- P970012MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS3PMA Approval
- P950029OPUS RM 4534 AND CHORUS RM 7034 PACEMAKERS3PMA Approval
- P890039POLY-SAFE(TM) A-TRACK(TM) PACING LEADS3PMA Approval
- P880086TRILOGY FAMILY OF PULSE GENERATORS3PMA Approval
- P900070TEMPO FAMILY OF PULSE GENERATORS3PMA Approval
- P880086APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04)3PMA Approval
- P970012MEDTRONIC VISION SOFTWARE MODEL 9952-SERIES 2.1 AND MEDTRONIC. VISION SOFTWARE MODEL 9952A-SERIES 2.13PMA Approval
- P880086SYNCHRONY, SOLUS, PHOENIX, PARAGON AND TRILOGY FAMILY OF PULSE GENERATORS3PMA Approval
- P900070TEMPO AND META PULSE GENERATORS3PMA Approval
- P880006REGENCY SC, SC+, AND SCX FAMILY OF PULSE GENERATORS3PMA Approval
- P950029CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER3PMA Approval
- P950037ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM3PMA Approval
- P890003MODEL 8090 ANALYZER MODEL 5436 ANALYZER PATIENT CABLE, 5104/5104ANALYZER ADAPTORS, AND 8190 ANALYZER SOFTWARE3PMA Approval
- P970012MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS3PMA Approval
- P880006APSU PROGRAMMER, APSU SOFTWARE, BASE STATION3PMA Approval
- P880086APSU PROGRAMMER, APSU SOFTWARE, BASE STATION3PMA Approval
- P880086APSU PROGRAMMER, APSU SOFTWARE, BASE STATION3PMA Approval
- P900070TEMPO PULSE GENERATORS3PMA Approval
- P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS3PMA Approval
- P950037ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM3PMA Approval
- P890003MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE3PMA Approval
- P910020COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS3PMA Approval
- P880086POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S3PMA Approval
- P880086POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S3PMA Approval
- P970012MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS3PMA Approval
- P890003MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE3PMA Approval
- P890003MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD3PMA Approval
- P890003MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE3PMA Approval
- P970012MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS3PMA Approval
- P910020COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS3PMA Approval
- P880006APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK3PMA Approval
- P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS3PMA Approval
- P910020MOMENTUM PACERS3PMA Approval
- P890003MODEL 9802 E REVEAL INSERTABLE LOOP RECORDER SOFTWARE3PMA Approval
- P880086TRILOGY DC+ MODEL 2318L PULSE GENERATOR3PMA Approval
- P890003PREVA, PRODIGY, VITATRON AND THERA PACEMAKERS3PMA Approval
- P910020EDGEBAND PACER RELAY MODEL 294-03E3PMA Approval
- P960004ADDITION OF ALTERNATE TUBING EXTRUDER3PMA Approval
- P900070TEMPO PULSE GENERATORS3PMA Approval
- P900070MODEL 1256D META MV CARDIAC PULSE GENERATOR3PMA Approval
- P880086APS III MODEL 3500 PROGRAMMER3PMA Approval
- P960004THINLINE ENDOCARDIAL PACING LEADS3PMA Approval
- P900070TEMPO VR 1102 AND TEMPO V 19023PMA Approval
- P900070TEMPO DR 2102 AND TEMP D 29023PMA Approval
- P900070META DDDR MODEL 1256 PULSE GENERATOR3PMA Approval
- P910020MOMENTUM PACERS3PMA Approval
- P880086TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L PULSE GENERATORS MODELS 2360L AND 2364L3PMA Approval
- P880006APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK3PMA Approval
- P880038MODEL 9602 PROGRAMMER3PMA Approval
- P900070MODEL 1256D META MV CARDIAC PULSE GENERATOR3PMA Approval
- P900070MODEL 1256D META MV CARDIAC PULSE GENERATOR3PMA Approval
- P880086TRILOGY SR+ MODEL 2260L & 2264L CARDIAC PULSE GENERATORS WITH THE MODEL 3023 PDX FUNCTION PACK3PMA Approval
- P950029CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER3PMA Approval
- P910020MARATHON PACING SYSYTEM3PMA Approval
- P880086TRILOGY DC + PULSE GENERATOR, MODEL 2318L3PMA Approval
- P900070META DDDR PACEMAKER PULSE GENERATORS MODELS 1256, 1256D, & 1256B (FORMERLY 1256R)3PMA Approval
- P880006SENSOLOG(R) CARDIAC PACING SYSTEM3PMA Approval
- P900070TEMPO DR 2102 AND TEMP D 29023PMA Approval
- P890003PREVA ST DR MODEL 7078 AND THE PREVA D MODEL 7068 IMPLANTABLE PULSE GENERATORS, AND MODEL 9559 SOFTWARE3PMA Approval
- P890003SYNERGYST II,ELITE & LEGEND PULSE GENERATORS3PMA Approval
- P890003MEDTRONIC 9766A/9766AL PROGRAMMING HEAD3PMA Approval
- P880006APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK3PMA Approval
- P910020MARATHON PACING SYSYTEM3PMA Approval
- P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS3PMA Approval
- P880086SYNCHRONY,SYNCHRONY II & III SOLUS, SOLUS II & TRIOLOGY PACEMAKERS3PMA Approval
- P880038META(TM) III PULSE GENERATOR MODELS 1206, 1206E, 1206M3PMA Approval
- P880086TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L PULSE GENERATORS MODELS 2360L AND 2364L3PMA Approval
- P890003MEDTRONIC 9891 BASELINE SOFTWARE/9891 A EPS3PMA Approval
- P910020RELAY/DASH/STRIDE/DART PACING SYSTEMS3PMA Approval
- P890003MEDTRONIC VDD STEROID-ELUTING LEAD3PMA Approval
- P910020UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR3PMA Approval
- P900070META DDDR PACING SYSTEM3PMA Approval
- P880038MEDA-MV PACING SYSTEM3PMA Approval
- P900070META DDDR PACING SYSTEM3PMA Approval
- P880038MEDA-MV PACING SYSTEM3PMA Approval
- P890039MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 3333PMA Approval
- P890003MEDTRONIC THERA, PRODIGY AND PREVA PULSE GENERATORS3PMA Approval
- P900070NETWORK PROGRAMMER MODEL 96023PMA Approval
- P880038NETWORK PROGRAMMER MODEL 96023PMA Approval
- P900070META DDDR PACING SYSTEM3PMA Approval
- P910020MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-663PMA Approval
- P910020RELAY/DASH/STRIDE/DART PACING SYSTEMS3PMA Approval
- P890003MEDTRONIC(R) THERA(R) VDD, MODEL 896I, PRODIGY(TM) VDD, MODEL 8168 PULSE GENERATORS AND CAPURE(R) VDD, MODEL 5032 LEAD,3PMA Approval
- P910020RELAY/DASH/STRIDE/DART PACING SYSTEMS3PMA Approval
- P910020RELAY/DASH/STRIDE/DART PACING SYSTEMS3PMA Approval
- P890003MEDTRONIC SYNERGYST II PULSE GENERATOR SYSTEM3PMA Approval
- P880006AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM3PMA Approval
- P880086AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM3PMA Approval
- P880086TRILOGY PULSE GENERATOR MODELS 235OL, 2250L, AND 2308L3PMA Approval
- P880086SYNCHRONY III AND PARAGON III DUAL-CHAMBER PULSE GENERATORS3PMA Approval
- P890003SYNERGYST II MEDTRONIC MODEL 9889E SOFTWARE3PMA Approval
- P890003MEDTRONIC(R) THERA(TM) PULSE GENERATORS3PMA Approval
- P890003MEDTRONIC(R) THERA(TM) PULSE GENERATORS3PMA Approval
- P880038MEDA-MV PACING SYSTEM3PMA Approval
- P890003MEDTRONIC(R) THERA(TM) PULSE GENERATORS3PMA Approval
- P870054KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS.3PMA Approval
- K940039PELLETHANE 75D3Cleared 510(K)
- P900070META DDDR PACING SYSTEM3PMA Approval
- P880086SYNCHRONY(R) CARDIAC PACING SYSTEM3PMA Approval
- P940031VIGOR(TM) DR PACEMAKER SYSTEM3PMA Approval
- P880086SYNCHRONY(R) CARDIAC PACING SYSTEM3PMA Approval
- P890003MEDTRONIC(R) THERA(TM) PULSE GENERATORS3PMA Approval
- P890039MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 3333PMA Approval
- K950751TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES3Cleared 510(K)
- K946188CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER3Cleared 510(K)
- K950210CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER3Cleared 510(K)
- P910020RELAY/DASH/STRIDE/DART PACING SYSTEMS3PMA Approval
- P880006SENSOLOG(R) CARDIAC PACING SYSTEM3PMA Approval
- P880086SYNCHRONY(R) CARDIAC PACING SYSTEM3PMA Approval
- P910020RELAY/DASH/STRIDE/DART PACING SYSTEMS3PMA Approval
- P890003MEDTRONIC(R) THERA(TM) PULSE GENERATORS3PMA Approval
- P890003MEDTRONIC(R) THERA(TM) PULSE GENERATORS3PMA Approval
- P890003MEDTRONIC DUAL CHAMBER PACEMAKERS3PMA Approval
- P880086SYNCHRONY(R) CARDIAC PACING SYSTEM3PMA Approval
- P910020UNITY - C MODEL 292-06 PULSE GENERATOR & ACCS.3PMA Approval
- P910020RELAY-DASH PACING SYSTEM3PMA Approval
- P910020RELAY-DASH PACING SYSTEM3PMA Approval
- P880006SENSOLOG (R) ULTILOG (TM) MODELS 2040K,2040T3PMA Approval
- P890003MEDTRONIC(R) MODEL 9870A SOFTWARE DISKETTES3PMA Approval
- P890003MEDTRONIC(R) THERA(TM) PULSE GENERATORS3PMA Approval
- P890003MEDTRONIC(R) THERA(TM) PULSE GENERATORS3PMA Approval
- P890039CCS MODEL 325 PACEMAKER SYSTEM3PMA Approval
- P890003MEDTRONIC(R) SYNERGYST II3PMA Approval
- P880086SYNCHRONY(R) CARDIAC PACING SYSTEM3PMA Approval
- P880086SYNCHRONY MODELS PARAGON III/PHOENIX III PACERS3PMA Approval
- P890003MEDTRONIC DUAL CHAMBER PACEMAKERS3PMA Approval
- P880086SYNCHRONY(R) CARDIAC PACING SYSTEM3PMA Approval
- P880006OG(R) CARDIAC PACING SYSTEM3PMA Approval
- P890003MEDTRONIC DUAL CHAMBER PACEMAKERS3PMA Approval
- K941937PIKOS E 01-B3Cleared 510(K)
- P880086SYNCHRONY(R) CARDIAC PACING SYSTEM3PMA Approval
- P880006SENSOLOG (R)MODEL 3039 FUNCTION PACK3PMA Approval
- P880086SYNCHRONY PACING SYS. MODEL 3039 FUNCTION PACK3PMA Approval
- P880086SYNCHRONY PACING SYS. MODEL 385 FUNCTION PACK3PMA Approval
- P910020RELAY-DASH PACING SYSTEM3PMA Approval
- P910020RELAY/DASH/STRIDE & DART PACING SYSTEM3PMA Approval
- K932884MINIX/MINIX ST PULSE GENERATORS3Cleared 510(K)
- P890039MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 3333PMA Approval
- P890003MEDTRONIC ELITE II(TM) PULSE GENERATOR3PMA Approval
- P880038MEDA-MV PACING SYSTEM3PMA Approval
- P900070META DDDR PACING SYSTEM3PMA Approval
- P890003MEDTRONIC SYNERGYST II PULSE GENERATOR3PMA Approval
- P890003MEDTRONIC ELITE II MODEL 70863PMA Approval
- P890039CCS MODEL 325 PACEMAKER SYSTEM3PMA Approval
- K923026PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER3Cleared 510(K)
- P890003MEDTRONIC MODEL 5424 ELECTROCARDIOGRAM CABLE3PMA Approval
- P900070META DDDR PACING SYSTEM MODEL 1254/FUNC.1250H3PMA Approval
- P890039CCS MODEL 333 PACEMAKER SYSTEM3PMA Approval
- P880038MODEL 9600 VERSION SC.11 PERSONALITY MODULE SOFT3PMA Approval
- P880086SOLUS (R) MODELS 2002,2003,SYNCHRONY(R)2022,20233PMA Approval
- P890003MEDTRONIC MODEL 9858 A SOFTWARE DISKETTES3PMA Approval
- K930770MEDTRONIC MINIX & MINIX ST PULSE GENERATORS3Cleared 510(K)
- K923868CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER3Cleared 510(K)
- P900070META DDDR PACING SYSTEM3PMA Approval
- P880038MEDA-MV PACING SYSTEM3PMA Approval
- P880038MODEL 9600 AUX.INSTRUMENTS INTERFACE CABLE3PMA Approval
- P900070CODEL 9600,4810,4510 5603,INTERFACE CABLE3PMA Approval
- P890039MAESTRO(R) SAVVI(TM) SERIES 305 VDD PACING SYSTEM3PMA Approval
- P890003MEDTRONIC MODEL 9858 SOFTWARE DISKETTES3PMA Approval
- P890039CCS MODEL 300 PACEMAKER MAESTRO3PMA Approval
- P880086SYNCHRONY(R)MODEL 2020T PULSE GEN.,& 3000 PROGRAMM3PMA Approval
- P880086SOLUS(R) II MODELS 2006L,2006T,2007K,2007M/S PULSE3PMA Approval
- P880006SENSOLOG (R) MODEL 3038 SOFTWARE MODIFICATION3PMA Approval
- P910020RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS3PMA Approval
- P880086SOLUS(TM) MODEL 2002L & SYNCHRONY II MODEL 2022L3PMA Approval
- P880006SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B3PMA Approval
- P900070MODEL 9600 PROG.,1250H GENERATOR SOFTWARE V4.10UE3PMA Approval
- P880038META III MODEL 1206,1206E,1206M PACING SYSTEMS3PMA Approval
- P910020RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS3PMA Approval
- P890003MODEL 9760 PROGRAMMING SYSTEM3PMA Approval
- P890003MEDTRONIC (R) ELITE II PULSE GENERATOR3PMA Approval
- P880006SENSOLOG (R) ALTERNATE PRODUCT TRAY3PMA Approval
- P880086SYNCHRONY(R)ALTERNATE PRODUCT TRAY3PMA Approval
- P890003MEDTRONIC MODELS ELITE,MINUET,& PRELUDE DR MODIF.3PMA Approval
- K920601ASTRA T2, ASTRA T4, ASTRA T63Cleared 510(K)
- P890039MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM3PMA Approval
- P890003MEDTRONIC MODEL 9855 SOFTWARE CHANGE3PMA Approval
- P880086SYNCHRONY(R) SOFTWARE CHANGE3PMA Approval
- P890039CCS MODEL 333 PACEMAKER INTRO. 3 NEW MODELS3PMA Approval
- P910020RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS3PMA Approval
- P890003ELITE & PRELUDE DR PULSE GENERATORS3PMA Approval
- P880086MODEL 3038 FUNCTION PACK FOR APS-II 3003 PROGRAMME3PMA Approval
- P880006MODEL 3038 FUNCTION PACK FOR ASP-II 3003 PROGRAMME3PMA Approval
- P890003MODEL 7074, 7075 AND 7077 ELITE(TM) PULSE GENERATO3PMA Approval
- P890003MODEL 9760 PROGRAMMING SYSTEM3PMA Approval
- P890003MODELS 7107,7108 MINUET PULSE GENERATORS3PMA Approval
- K920530INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG3Cleared 510(K)
- K920157SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER3Cleared 510(K)
- P880038META II MODEL 1204H CARDIAC PACING SYSTEM3PMA Approval
- P890003MODEL 7074, 7075 AND 7077 ELITE(TM) PULSE GENERATO3PMA Approval
- K914109PIKOS 01 & PIKOS E 013Cleared 510(K)
- P880006SENSOLOG(R)III & DIALOG(R)II PULSE GENERATORS3PMA Approval
- P900070META DDDR PACING SYSTEM3PMA Approval
- P880038META II MODEL 1204 CARDIAC PACING SYSTEM3PMA Approval
- P890039MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM3PMA Approval
- P890039POLYSAFE(TM) A-TRACK(TM) MODEL AT-332 ENDOCARDIAL3PMA Approval
- P880006MODEL 3037A FUNCTION PACK3PMA Approval
- P880086MODEL 3037A FUNCTION PACK3PMA Approval
- P890003MODELS 7070,7071,7071M,SYNERGEST(TM)II PULSE GEN3PMA Approval
- P880038META MV MODEL 1202 CARDIAC PACING SYSTEM3PMA Approval
- P890003MODEL 9855 SOFTWARE SYSTEM3PMA Approval
- K905403MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER3Cleared 510(K)
- P880038META II MODEL 1204 CARDIAC PACING SYSTEM3PMA Approval
- P890039MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM3PMA Approval
- P890039MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM3PMA Approval
- P880086SENSOLOG 2020T, SESOLOG II 2022T, SOLUS 200T3PMA Approval
- P880086APS-11 MODEL 3003 PROGRAMMER3PMA Approval
- P880006APS-II MODEL 3003 PROGRAMMER3PMA Approval
- P880006SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B3PMA Approval
- K913134MODEL 42203Cleared 510(K)
- P880086SOLUS 2002,2003 & SYNCHRONY II 2022,2023 PULSE GEN3PMA Approval
- P890003MODEL 9852 SOFTWARE SYSTEM3PMA Approval
- K912545MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE3Cleared 510(K)
- P890003SYNERGYST(TM) II MODELS 7070/7071 (M) (A)3PMA Approval
- P880086SOLUS(TM) MODEL 2002L & SYNCHRONY II MODEL 2022L3PMA Approval
- K9111228MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS3Cleared 510(K)
- K905824MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE3Cleared 510(K)
- K905087TRIOS 023Cleared 510(K)
- P890039MAESTRO(R) MODEL 1006P PACEMAKER PROGRAMMER3PMA Approval
- P890003MEDTRONIC ELITE(TM) MODELS 7074,7075,7076,& 70773PMA Approval
- P880086SYNCHRONY II MODEL 2023M/S & SOLAS MODEL 2003M/S3PMA Approval
- P880086SYNCHRONY II MODEL 2023M/S & SOLAS MODEL 2003M/S3PMA Approval
- K903186OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE3Cleared 510(K)
- K904941MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE3Cleared 510(K)
- K904602MEDTRONIC MODEL 5301B TEST CABLE3Cleared 510(K)
- P890003MEDTRONIC SYNERGYST II MODEL 7070 PULSE GENERATOR3PMA Approval
- K904892VACUUM BAKE CYCLE3Cleared 510(K)
- P880086SYNCHRONY MODEL 2020T CARDIAC PACING SYSTEM3PMA Approval
- P890003MEDTRONIC SYNERGYST II MODEL 7070 PULSE GENERATOR3PMA Approval
- P880038META MV MODEL 1202 CARDIAC PACING SYSTEM3PMA Approval
- P870054MODEL K (UNIPOLAR) & M (BIPOLAR) ENDOCARDIAL LEADS3PMA Approval
- K903919IMPLANTABLE PULSE DEVICES3Cleared 510(K)
- P880038META MV MODEL 1202 CARDIAC PACING SYSTEM3PMA Approval
- P880038META MV MODEL 1202 CARDIAC PACING SYSTEM3PMA Approval
- P890039MASTRO SAVVI SERIES 300 VDD PACING SYSTEM3PMA Approval
- P880038META MV MODEL 1202 CARDIAC PACING SYSTEM3PMA Approval
- K903081NEOS (TM) 02 B PULSE GENERATOR3Cleared 510(K)
- P880038META DDD MODEL 1230 PACER3PMA Approval
- P880038META-MV,PACING SYSTEM3PMA Approval
- K902134MINIX, MINIX ST, NEW IC: L743Cleared 510(K)
- K901535MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.3Cleared 510(K)
- P870054MODEL Q (UNIPOLAR) & R (BIPOLAR) ENDOCARDIAL LEADS3PMA Approval
- P880086SYNCHRONY II MODELS 2022T & 2023M - 2002T & 2003M3PMA Approval
- P880006SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B3PMA Approval
- P880038META MV MODEL 1202 & 1202 PULSE GENERATORS3PMA Approval
- P880086MODEL 3033C FUNCTION PACT3PMA Approval
- P880086MODEL 3003 PROGRAMMER MODEL 3036B FUNCTION PACK3PMA Approval
- P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM3PMA Approval
- K900622MODIFIED MODEL 5401B TEST CABLE3Cleared 510(K)
- P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM3PMA Approval
- P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM3PMA Approval
- P880038META DDD MODEL 1230 PACER3PMA Approval
- P870054KELVIN (R) PACING SYSTEM3PMA Approval
- K900461OPUS MODEL 4021, VVI, 5MM UNIPOLAR3Cleared 510(K)
- K897116OPTIMA MPT MODEL 5281E AND MODEL 5282E3Cleared 510(K)
- P880038META DDD MODEL 1230 PACER3PMA Approval
- K896809MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR3Cleared 510(K)
- P880038META-MV,PACING SYSTEM3PMA Approval
- P890003SYSNERGYST II PULSE GENERATOR MODELS 7070 & 70713PMA Approval
- P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM3PMA Approval
- P880086SYNCHRONY II MODELS 2022T & 2023M - 2002T & 2003M3PMA Approval
- K896184KALOS 05 PULSE GENERATOR3Cleared 510(K)
- P890003SYSNERGYST II PULSE GENERATOR MODELS 7070 & 70713PMA Approval
- P870054KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR3PMA Approval
- K894239NANOS3Cleared 510(K)
- K894240NEOS 023Cleared 510(K)
- K894494LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD3Cleared 510(K)
- P880038META-MV,PACING SYSTEM3PMA Approval
- K895495ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS3Cleared 510(K)
- K894065OPUS MODEL 40013Cleared 510(K)
- K894267OPUS MODELS 4033 AND 40343Cleared 510(K)
- P870054KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR3PMA Approval
- P880086SYNCHRONY MODEL 2020T PULSE GENERATOR3PMA Approval
- P880038META-MV,PACING SYSTEM3PMA Approval
- K891231OPTIMA MPT AND SPT PACEMAKERS3Cleared 510(K)
- P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM3PMA Approval
- K894055MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS3Cleared 510(K)
- K884420HOME BLOOD PRESSURE KIT, ANEROID3Cleared 510(K)
- P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS3PMA Approval
- K894185OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR3Cleared 510(K)
- P870054KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR3PMA Approval
- P880038META-MV,PACING SYSTEM3PMA Approval
- P870054KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR3PMA Approval
- P880038META-MV,PACING SYSTEM3PMA Approval
- P880038META-MV,PACING SYSTEM3PMA Approval
- P870054KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR3PMA Approval
- K885267VS-1 MODEL NUMBER 251K PULSE GENERATOR3Cleared 510(K)
- P870054KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR3PMA Approval
- K890785ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE3Cleared 510(K)
- P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM3PMA Approval
- K884733AFP MODEL 262T PULSE GENERATOR3Cleared 510(K)
- K884411OPTIMA MPT AND SPT PACEMAKERS3Cleared 510(K)
- K883037UNILITH 3 MODELS 7580/7583/7680/76833Cleared 510(K)
- K883750VENTRALITH I3Cleared 510(K)
- K884215MINIX 8340, 8341, 8342 MINIX-ST 8330, 83313Cleared 510(K)
- K883755MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS3Cleared 510(K)
- K882391OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,40243Cleared 510(K)
- K884023MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER3Cleared 510(K)
- K882427CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/40663Cleared 510(K)
- K883087PROLOG MP 658M PULSE GENERATOR3Cleared 510(K)
- K882474OPUS PULSE GENERATORS MODELS 2001, 2003 AND 20043Cleared 510(K)
- K882476OPUS PULSE GENERATORS MODELS 3001, 3003 AND 30043Cleared 510(K)
- K881904CHANGE TO CATHODE POWDER SPECIFICATION3Cleared 510(K)
- K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D3Cleared 510(K)
- K881711VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA.3Cleared 510(K)
- K880898MULTICOR AND PACEMAKERS3Cleared 510(K)
- P870054KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR3PMA Approval
- K880326MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS3Cleared 510(K)
- K880422MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER3Cleared 510(K)
- K880432VICOR PACER, MODEL 410A3Cleared 510(K)
- K873158MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS3Cleared 510(K)
- K874158CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.3Cleared 510(K)
- K874394QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.3Cleared 510(K)
- K872766IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS3Cleared 510(K)
- K872779PROLOG MP PULSE GENERATORS 658K AND 658T3Cleared 510(K)
- K873202VICOR, MODEL 410A3Cleared 510(K)
- K873528MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS3Cleared 510(K)
- K871992IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS3Cleared 510(K)
- K871866MEDTRONIC CLASSIX MODELS 8436/8437/84383Cleared 510(K)
- K871861IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS3Cleared 510(K)
- K870142PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR3Cleared 510(K)
- K865013ASTRA T2, T4 AND T63Cleared 510(K)
- K863898MULTILITH 3 MODELS 1350, 3350, 1370, 33703Cleared 510(K)
- K862226DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS3Cleared 510(K)
- K860036EDP-20 PACEMAKER3Cleared 510(K)
- K862459MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE3Cleared 510(K)
- K863878TRIOS-M VS-1 PULSE GENERATOR3Cleared 510(K)
- K863879NEOS-M VS-1 PULSE GENERATOR3Cleared 510(K)
- K863582MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)3Cleared 510(K)
- K863417CORDIS MULTICOR II MODEL 402D PACER3Cleared 510(K)
- K863365MODIFICATION OF STERILITY CYCLE PARAMETERS3Cleared 510(K)
- K863418MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE3Cleared 510(K)
- K862974ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.3Cleared 510(K)
- K854790CERYX PACEMAKER MODELS 114, 314 & 6143Cleared 510(K)
- K860921NEOS VS-1, PULSE GENERATOR3Cleared 510(K)
- K860922MIKROS, MIKROS VS-1, PULSE GENERATOR3Cleared 510(K)
- K860585ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR3Cleared 510(K)
- K853771PINNACLE MULTI-PROGRAMMABLE PACING SYS3Cleared 510(K)
- K861719MODIFIED MODELS 8320/8322/8329/8316/8317/83183Cleared 510(K)
- K861422PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY3Cleared 510(K)
- K862071MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN3Cleared 510(K)
- K862038MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER3Cleared 510(K)
- K862037MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN3Cleared 510(K)
- K860573IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR3Cleared 510(K)
- K861559SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS3Cleared 510(K)
- K861140PROGRAMALITH III PULSE GENERATOR3Cleared 510(K)
- K861009BIPOLAR CARDIAC PACEMAKER, MODEL 1103Cleared 510(K)
- K852973UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 77623Cleared 510(K)
- K855147MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS3Cleared 510(K)
- K855081PHOENIX MODELS 250/251 PULSE GENERATORS3Cleared 510(K)
- K854482ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS3Cleared 510(K)
- K860466MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.3Cleared 510(K)
- K860202MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.3Cleared 510(K)
- K853471CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA3Cleared 510(K)
- K853400CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK3Cleared 510(K)
- K855171TELEMETRY WAND MODEL3Cleared 510(K)
- K854560IMPLANTABLE PROGRAMMABLE PULSE GENERATOR3Cleared 510(K)
- K852641ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER3Cleared 510(K)
- K851968CORDIS MULTICOR ST, MODEL 350A3Cleared 510(K)
- K854195PROGRAMALITH III MODELS 238 & 2393Cleared 510(K)
- K854919BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY3Cleared 510(K)
- K854214MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE3Cleared 510(K)
- K854132COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS3Cleared 510(K)
- K851365SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM3Cleared 510(K)
- K852339SUPRIMA MODEL 254-223Cleared 510(K)
- K852340SUPRIMA MODEL 254-243Cleared 510(K)
- K854143BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS3Cleared 510(K)
- K852748CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK3Cleared 510(K)
- K852688MEDTRONICS MODELS 8320/8322/83293Cleared 510(K)
- K853651COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER3Cleared 510(K)
- K853590COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI3Cleared 510(K)
- K853058NEOS - M ABP3Cleared 510(K)
- K853206IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW3Cleared 510(K)
- K853057TRIOS - M3Cleared 510(K)
- K853425CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR3Cleared 510(K)
- K852435CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA3Cleared 510(K)
- K853034#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ3Cleared 510(K)
- K853017ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&22513Cleared 510(K)
- K852431SUPRIMA II MODEL 254-263Cleared 510(K)
- K852430SUPRIMA II MODEL 253-233Cleared 510(K)
- K852432SUPRIMA II MODEL 254-283Cleared 510(K)
- K851420MULTICOR S, MODELS 330A/331A3Cleared 510(K)
- K844360CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS3Cleared 510(K)
- K851416STANICOR GAMMA 333B/334A3Cleared 510(K)
- K851418OMNI-ATRICOR MODEL 308A3Cleared 510(K)
- K851417MULTICOR GAMMA MODELS 336/3373Cleared 510(K)
- K851419MULTICOR GAMMA 402 SERIES PACER3Cleared 510(K)
- K851861PROGRAMALITH III MODEL 249 PULSE GENERATOR3Cleared 510(K)
- K851699COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE3Cleared 510(K)
- K850464PROGRAMALITH III 240 PULSE GENERATOR3Cleared 510(K)
- K844841KALOS-04 PULSE GENERATOR3Cleared 510(K)
- K844842NEOS-LP PULSE GENERATOR3Cleared 510(K)
- K844812NEOS - PULSE GENERATOR3Cleared 510(K)
- K844795NEOS-M PULSE GENERATOR3Cleared 510(K)
- K844794LEPTOS PULSE GENERATOR3Cleared 510(K)
- K851081IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II3Cleared 510(K)
- K850252QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR3Cleared 510(K)
- K850651PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR3Cleared 510(K)
- K850384CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER3Cleared 510(K)
- K850656COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM3Cleared 510(K)
- K842051EKG TRANSMITTER MODEL 51343Cleared 510(K)
- K844957MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR3Cleared 510(K)
- K844958MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE3Cleared 510(K)
- K844793SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR3Cleared 510(K)
- K844334VIVALITH II 301 PULSE GENERATOR3Cleared 510(K)
- K842193MULTILITH PULSE GENERATORS, 1141 & 21413Cleared 510(K)
- K841230PULSE GENERATOR 686, 686B 686L3Cleared 510(K)
- K841225PULSE GENERATOR 689, 689B & 689L3Cleared 510(K)
- K841232PULSE GENERATOR 696, 696B & 696L3Cleared 510(K)
- K842220MULTILITH 2 PULSE GENERATOR 1141 & 21413Cleared 510(K)
- K842473IMPLANTABLE PROGRAMMABLE PULSE GENERAT3Cleared 510(K)
- K843837MEDTRONIC 5984-5984LP-59853Cleared 510(K)
- K842394ASTRA 2, ASTRA 3, 4 & 63Cleared 510(K)
- K843089MEDTRONIC 8437/84383Cleared 510(K)
- K841633NEOS LP3Cleared 510(K)
- K841635LEPTOS3Cleared 510(K)
- K840748LITHIUM PACEMAKER 811-811L & 811XL3Cleared 510(K)
- K841983COOK PACEMAKER 216 BIPOLAR CARDIAC -3Cleared 510(K)
- K841928COOK PACEMAKER 215 UNIPOLAR CARDIAC-3Cleared 510(K)
- K842081COOK PACEMAKER CORP. 115 UNIPOLAR CARDI3Cleared 510(K)
- K841233PULSE GENERATOR 678L3Cleared 510(K)
- K841231PULSE GENERATOR 688B & 688L3Cleared 510(K)
- K841228PULSE GENERATOR 718B & 718L3Cleared 510(K)
- K841226PULSE GENERATOR 728, 728B & 728L3Cleared 510(K)
- K841950PULSE GENERATOR KALOS-043Cleared 510(K)
- K841636NEOS M3Cleared 510(K)
- K841229PULSE GENERATOR 698, 698B & 698L3Cleared 510(K)
- K841404PRIMA 236-02 NONPROGRAMMABLE CARDIAC3Cleared 510(K)
- K841074CARDIAC PULSE GENERATOR 254-183Cleared 510(K)
- K841075CARCIAC PULSE GENERATOR 254-203Cleared 510(K)
- K841073QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE3Cleared 510(K)
- K840737IMPLANTABLE PROGRAMMABLE PULSE GENER3Cleared 510(K)
- K840701PACEMAKER 147 VVI-THE OPTINIA3Cleared 510(K)
- K833427IMPLANTABLE BIPOLAR CARDIAC PULSE GEN3Cleared 510(K)
- K833428IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN3Cleared 510(K)
- K833519PULSE GENERATOR MODEL 6883Cleared 510(K)
- K834096IMPLANTABLE PULSE GENERATOR3Cleared 510(K)
- K833798OPTIMA MDT PULSE GENERATOR W/TELEMETRY3Cleared 510(K)
- K832914PRIMA-UNIPOLAR CARDIAC PULSE GENERAT3Cleared 510(K)
- K833199SILICONE RUBBER ISOLATION SLEEVE 350-013Cleared 510(K)
- K833198SILICONE RUBBER ISOLATION SLEEVE 351-013Cleared 510(K)
- K831860GENERATOR, PULSE, PACEMAKER #5323Cleared 510(K)
- K831859PACEMAKER PROGRAMMER #20323Cleared 510(K)
- K831633QUANTUM BIPOLAR CARDIAC PULSE GENERATOR3Cleared 510(K)
- K832893MODEL 329T PROGRAMMABLE, BIPOLAR CARDI3Cleared 510(K)
- K831771IMPLANTABLE PROGRAM. CARDIAC PULSE GEN3Cleared 510(K)
- K832052MODEL 327T UNIPOLAR CARDIAC PULSE GEN3Cleared 510(K)
- K831216COMMAND ULTRA II3Cleared 510(K)
- K831161COMMAND ULTRA I3Cleared 510(K)
- K830344SIEMENS-ELMA PULSE GENERATOR #7183Cleared 510(K)
- K830862NEDS-01 & EPR-5003Cleared 510(K)
- K830390IMPLANTABLE BIPOLAR CARDIAC PULSE GEN3Cleared 510(K)
- K823878IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 2423Cleared 510(K)
- K830401UNILITH PULSE GENERATOR VVI #75423Cleared 510(K)
- K830382COMMAND ULTRA II3Cleared 510(K)
- K823831MEDTRONIC MODELS 59401 59413Cleared 510(K)
- K823863CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC3Cleared 510(K)
- K823559AFP PULSE GENERATOR3Cleared 510(K)
- K822639AFP SYSTEM PULSE GENERATOR MODEL 261/2623Cleared 510(K)
- K823678TELEMETRY DECODER #540-023Cleared 510(K)
- K823371DURAPULSE3Cleared 510(K)
- K822791CORATOMIC #VX5-105 & VX5-205 PULSE GEN.3Cleared 510(K)
- K822907KALOS-03 BIPOLAR3Cleared 510(K)
- K822904MODEL 325D UNIPOLAR CARDIAC PULSE GEN3Cleared 510(K)
- K822652JAIN INSULATING BOOT MODEL 225B3Cleared 510(K)
- K822309COMMAND NP3Cleared 510(K)
- K822297ENERTRAX MODEL 7100E3Cleared 510(K)
- K822147MEDTRONIC ENERTRAX MODEL 71003Cleared 510(K)
- K820939C-101-P3Cleared 510(K)
- K821033CORATOMIC MODEL OVALITH-9203Cleared 510(K)
- K821014CORATOMIC MODEL OVALITH 920BP3Cleared 510(K)
- K821147COOK #326T PROGRAM/TELEMETRY BIPOLAR3Cleared 510(K)
- K821073PULSE GENERATOR3Cleared 510(K)
- K821003PROGRAMMALITH II, #225 & 2263Cleared 510(K)
- K820657PULSE GENERATOR 678 B3Cleared 510(K)
- K820853QUANTUM MODELS 253-09, 254-09 254-103Cleared 510(K)
- K820774IMPLANTABLE, MULTIPROGRAMMABLE3Cleared 510(K)
- K820356MULTICOR (GAMMA) 402 CARDIAC PACER3Cleared 510(K)
- K820231COMMAND ULTRA I3Cleared 510(K)
- K813246MEDICAL MULTILITH PULSE GENERA-11403Cleared 510(K)
- K813576SIEMENS-ELEMA PULSE GENERATOR 6593Cleared 510(K)
- K813534COMMAND P53Cleared 510(K)
- K813079BIPOLAR OPTIMA MP #2553Cleared 510(K)
- K812610SIEMENS-ELEMA PULSE GENERATOR 668 B3Cleared 510(K)
- K813150DIRECTIONAL BOOT3Cleared 510(K)
- K813101CARDIOBEEPER MEMORY MONITOR3Cleared 510(K)
- K812464SYNTHEMED PULSE GENERATOR VVI MODEL 10003Cleared 510(K)
- K812832MODEL 325C UNIPOLAR CARDIAC PULSE GEN.3Cleared 510(K)
- K812790IMPLANTABLE VENTRICULAR-INHIBITED CARDI3Cleared 510(K)
- K812358MODEL 325T PROGRAMMABLE PULSE GENERATOR3Cleared 510(K)
- K812218KALOS-033Cleared 510(K)
- K812580MEDTRONIC MODEL 24093Cleared 510(K)
- K801337CYBERLITH IX IMPLANTABLE PULSE GENERATOR3Cleared 510(K)
- K801339TELEMETRY DECODER3Cleared 510(K)
- K812096MEDTRONIC ENERTRAX MODEL 71003Cleared 510(K)
- K812153MEDTRONIC SPECTRAX3Cleared 510(K)
- K811402COMMAND P5(BIPOLAR PULSE GENERATOR)3Cleared 510(K)
- K811768CORATOMIC MODEL OVALITH-920BP3Cleared 510(K)
- K811691CORDIS OMNI-ARTICOR CARDIAC PACER #3083Cleared 510(K)
- K810887ELA MEDICAL UNILITH 7540 PULSE GENERATOR3Cleared 510(K)
- K811350UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.3Cleared 510(K)
- K810884#325 PROGRAMMABLE CARD. PULSE GENERATOR3Cleared 510(K)
- K810885#326 PROGRAMMABLE CARD. PULSE GENERATOR3Cleared 510(K)
- K810489MULTILITH PULSE GENERATOR #11403Cleared 510(K)
- K810142ELA MEDICAL UNILITH PULSE GENERATOR3Cleared 510(K)
- K811221INTERMEDICS CYBERLITH BIPOLAR CARDIAC3Cleared 510(K)
- K811123MEDTRONIC PULSE GENERATOR3Cleared 510(K)
- K810677MODELS 5976/5977 PACEMAKER PULSE GENER3Cleared 510(K)
- K810808CORATOMIC MODEL OVALITH-9203Cleared 510(K)
- K810734MODELS 8420 THRU 8423 PACEMAKER GENER3Cleared 510(K)
- K811066MODEL 230-06 CYBERLITH TM I BIPOLAR IN3Cleared 510(K)
- K810800MODEL 230-05 CYBERLITH I BIPOL. PULSE G.3Cleared 510(K)
- K810752THINLITH III UNIPOLAR CARDIAC PULSE GEN.3Cleared 510(K)
- K810901INSULATIVE COATING FOR CARD. PULSE GEN3Cleared 510(K)
- K810603IMPLANTABLE PROGRAMMABLE CARDIAC PULSE3Cleared 510(K)
- K810385CYBERLITH I PULSE GENERATOR MODEL 253-043Cleared 510(K)
- K810383INTERMEDICS CYBERLITH I BIOPOLAR CARDI3Cleared 510(K)
- K810386THINLITH II PULSE GNEERATOR MODEL 227-053Cleared 510(K)
- K810410STERILE PACKAGING3Cleared 510(K)
- K810121UNIFOCAL 33Cleared 510(K)
- K801584MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.3Cleared 510(K)
- K802864SIEMENS-ELEMA PULSE GENERATOR 6783Cleared 510(K)
- K810036SIEMENS-ELEMA MYOCARDIAL LEAD3Cleared 510(K)
- K803197IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#2743Cleared 510(K)
- K801338CYBERLITH PROGRAMMER3Cleared 510(K)
- K803035MICROTHIN-PII BIPOLAR PULSE GEN. #06213Cleared 510(K)
- K803034MICROTHIN-PII BIPOLAR PULSE GEN. #06233Cleared 510(K)
- K802352MICRO THIN-DII, #05213Cleared 510(K)
- K802353MICRO THIN-PII, #05233Cleared 510(K)
- K800746UNIFOCAL VP, MODELS 7501 AND 75023Cleared 510(K)
- K801324SIEMENS-ELEMA PULSE GENERATOR 6683Cleared 510(K)
- K802588MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.3Cleared 510(K)
- K792609LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN.3Cleared 510(K)
- K802410MICROTHIN-PI BIPOLAR PULSE GENERATOR3Cleared 510(K)
- K802409MICROTHIN-DI BIPOLAR PULSE GENERATOR3Cleared 510(K)
- K801640SORIN PULSE GENERATOR, MODEL #LIT-2143Cleared 510(K)
- K802028IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN3Cleared 510(K)
- K801978PROGRAMALITH #'S 221, 222, 221A & 222A3Cleared 510(K)
- K800379BIFOCAL 2 8200 SERIES (A,B C,D)3Cleared 510(K)
- K800793IMPLANTABLE PROGRAM. CARDIAC PACEMAKER3Cleared 510(K)
- K801508SIEMENS-ELEMA PULSE GENERATOR 6253Cleared 510(K)
- K801910INSULATING SHEATH3Cleared 510(K)
- K802040BATTERY FOR #229-01 PULSE GENERATOR3Cleared 510(K)
- K801806EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE3Cleared 510(K)
- K800226MEDTRONIC MODEL 24093Cleared 510(K)
- K801763VIVALITH 5, - MDL-201A & TDL-201A3Cleared 510(K)
- K801647SONACOLOR 61003Cleared 510(K)
- K801450INTERMEDICS THIN LITH IV SERIES UNIPOLAR3Cleared 510(K)
- K801106MULTICOR (GAMMA) MODEL 336 & MODEL 3373Cleared 510(K)
- K801241UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.3Cleared 510(K)
- K801122MICROTHIN-D1 (MOD. 0620)3Cleared 510(K)
- K801121MICROTHIN-P1 (MOD. 0622)3Cleared 510(K)
- K800837PROGRAMMABLE BIPOLAR CARDIAC GENERATOR3Cleared 510(K)
- K800069MEDTRONIC MODELS 5966/5967, ETC.3Cleared 510(K)
- K800838ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.3Cleared 510(K)
- K800285MODEL 5985 PACEMAKER PULSE GENERATOR3Cleared 510(K)
- K800387PULSE GENERATORS MODELS 657 & 6773Cleared 510(K)
- K800895MODEL 253-11 CYBERLITH PULSE GENERATOR3Cleared 510(K)
- K800644CYBERLITH IMPLANTABLE PULSE GEN. #253-023Cleared 510(K)
- K800375NOMOS-01 PULSE GENERATOR3Cleared 510(K)
- K800645CYBERLITH IMPLANTABLE PULSE GEN. #253-043Cleared 510(K)
- K800573IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC3Cleared 510(K)
- K800326ARCOLITH 3021-CARDIAC PULSE GENERATOR3Cleared 510(K)
- K800194OVALITH P-BP BIPOLAR CARDIAC PACEMAKER3Cleared 510(K)
- K792565SORIN PULSE GENERATOR MODEL # LIT 214 H3Cleared 510(K)
- K792526PULSE GENERATOR, MODEL NO. LIT 2223Cleared 510(K)
- K800027MICROTHIN-PI3Cleared 510(K)
- K800026MICROTHIN-DI3Cleared 510(K)
- K800030IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.3Cleared 510(K)
- K792519IMPLANTABLE PROGRAMMABLE UNIPOLAR3Cleared 510(K)
- K792299ARCOLITH 3020-CARDIAC PULSE GENERATOR3Cleared 510(K)
- K792216ARCOLITH 2100-CARDIAC PULSE GENERATOR3Cleared 510(K)
- K791920CARDIAC PACEMAKER P4000 SER. & P10003Cleared 510(K)
- K792232UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR3Cleared 510(K)
- K792199UNIFOCAL 2-UNIPOLAR & BIPOLAR3Cleared 510(K)
- K791955UNIFOCAL 1 UNIPOLAR DEMAND R WAVE3Cleared 510(K)
- K791316MEDTRONIC MODELS 5984/59853Cleared 510(K)
- K791921CARDIAC PACEMAKER C4000, C1000 SER.3Cleared 510(K)
- K792052IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD3Cleared 510(K)
- K791783OMNI-STANICOR (THETA) MOD 237A3Cleared 510(K)
- K790792PULSE GENERATOR MODEL 6373Cleared 510(K)
- K791784CORDIS BIPOLAR PACER CONNECTOR SYSTEM3Cleared 510(K)
- K790068PULSE GENERATORS, MODELS 5983, 59893Cleared 510(K)
- K791727IMPLANTABLE VENTRICULAR-INHIBITED3Cleared 510(K)
- K791715ARCOLITH 20003Cleared 510(K)
- K791751EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR3Cleared 510(K)
- K791181PROGRAMMER, MEDTRONIC MODEL 5984/59853Cleared 510(K)
- K790873MODEL 221 PROGRAMALITH PULSE GENERATOR3Cleared 510(K)
- K791568IMPLANTABLE PULSE GENERATOR PACEMAKERS3Cleared 510(K)
- K791379MODEL 228-02 THINLITH II PACEMAKER, BIPO3Cleared 510(K)
- K791678LITHICRON II 0403 IMPLANTABLE PACEMAKER3Cleared 510(K)
- K791417IMPLANTABLE PULSE GENERATOR PACEMAKER3Cleared 510(K)
- K791225BJORK-SHILEY AORTIC GRAFT VALVE PROSTH3Cleared 510(K)
- K791095LITHICRON MODEL 0401, PACEMAKER3Cleared 510(K)
- K790428MDL-201A & T DL-201A PULSE GENERATOR3Cleared 510(K)
- K790141PULSE GENERATOR, R WAVE DEMAND3Cleared 510(K)
- K791147ARCO PROGAMMABLE PACEMAKER SYSTEM3Cleared 510(K)
- K791219UNILITH PULSE GENERATOR3Cleared 510(K)
- K790446OVALITH-3003Cleared 510(K)
- K782162BATTERY CHARGER, 171 PACEMAKER3Cleared 510(K)
- K782161PULSE GENERATOR, MODEL 1713Cleared 510(K)
- K791165ARCOLITH 40003Cleared 510(K)
- K790670PULSE GENERATOR MODEL 6293Cleared 510(K)
- K791093MODELS 2411/2418 VENTRICULAR-INHIBITED3Cleared 510(K)
- K790666VITALITH S 3000 SERIES3Cleared 510(K)
- K790867CARDIAC PULSE GENERATOR, 16 SERIES3Cleared 510(K)
- K790868GENERATOR, 16 SERIES, MODIFIED TOP CAP3Cleared 510(K)
- K790690OMNI-STANICOR-(THETA) MODEL 2173Cleared 510(K)
- K790562PULSE GENERATOR MODEL 61 AND 1283Cleared 510(K)
- K79045228 UNIPOLAR AND BIPOLAR PULSE GENERATORS3Cleared 510(K)
- K790764PACEMAKERS WITHOUT SILASTIC COATING3Cleared 510(K)
- K781973CARDIOPHONE3Cleared 510(K)
- K790432MICROLITH MODELS 505;605;507;607;703;8033Cleared 510(K)
- K790566PACEMAKER, OVALITH-D CARDIAC3Cleared 510(K)
- K790276MINILITH AND MICROLITH3Cleared 510(K)
- K790014BIPOLAR, STANICOR LAMBDA MODEL 236,2353Cleared 510(K)
- K782149PULSE GENERATOR, IMPLANTABLE CARDIAC3Cleared 510(K)
- K790099ISOLATION SLEEVE, MODEL 347-013Cleared 510(K)
- K790098ISOLATION SLEEVE, MODEL 349-013Cleared 510(K)
- K790100ISOLATION SLEEVE, MODEL 348-013Cleared 510(K)
- K790101ISOLATION SLEEVE, MODEL 346-013Cleared 510(K)
- K782146PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT3Cleared 510(K)
- K782023MICROLITH A MODEL 8033Cleared 510(K)
- K782022MICROLITH A MODEL 7033Cleared 510(K)
- K780430LITHICRON F PROGRAMMABLE PULSE GEN3Cleared 510(K)
- K781835PULSTRON MODEL 1003Cleared 510(K)
- K781738PACEMAKER, MODEL 229-013Cleared 510(K)
- K780897GENERATOR, PULSE, SORIN MODEL DL-13Cleared 510(K)
- K781377OVALITH 10BP3Cleared 510(K)
- K781252GENERATOR, PULSE, MODEL 59973Cleared 510(K)
- K781208GENERATORS, PULSE, MODELS 5988/59893Cleared 510(K)
- K780776ARCOBIOLITH PACEMAKER MODEL3Cleared 510(K)
- K781424GENERATORS: UDL-201B, BDL-201B, MDL-201B3Cleared 510(K)
- K780940GENERATOR, PULSE, MODEL 160B3Cleared 510(K)
- K772226PACEMAKER, MODEL 225 & 2273Cleared 510(K)
- K781426CARDIAL PULSE GENERATORS3Cleared 510(K)
- K781178PULSE GENERATOR MODEL 2083Cleared 510(K)
- K781090GENERATOR, CARDIAC PULSE, 250B3Cleared 510(K)
- K781168GENERATOR, PULSE, PACEMAKER3Cleared 510(K)
- K780809GENERATOR, PULSE MODELS 5920/59213Cleared 510(K)
- K780741GENERATOR, PULSE, DEMAND, MODEL 59963Cleared 510(K)
- K781042PROLITH 23S PACEMAKER3Cleared 510(K)
- K780781STILITH CARDIAC PACEMAKERS-M. 60 & 1203Cleared 510(K)
- K780561VENTRICULAR INHIBITED PULSE GENERATOR3Cleared 510(K)
- K780420GENERATOR, PULSE, CARDIAC, IMPLANTABLE3Cleared 510(K)
- K780421GENERATOR, PULSE, CARDIAC, IMPLANTABLE3Cleared 510(K)
- K780780MICROPULSE 22S PACEMAKER3Cleared 510(K)
- K780453STANICOR THETA MODEL 221 CARDIAC PACER3Cleared 510(K)
- K780327GENERATORS, ATRIAL INHIBITED PULSE3Cleared 510(K)
- K780777BAGS, PLASTIC, STERILE FOR GENERATORS3Cleared 510(K)
- K780437PACEMAKER, MODEL 252, C-MOS3Cleared 510(K)
- K780238PACEMAKER, PROLITH 23U. PULSE GENERATOR3Cleared 510(K)
- K780113CARDIAC PULSE GENERATOR, MODEL 160B3Cleared 510(K)
- K780091MICROPULSE 22U3Cleared 510(K)
- K780066CARDIAC PACER, MODEL 2083Cleared 510(K)
- K772240PULSE GENERATOR, UNIPOLAR, DEMAND3Cleared 510(K)
- K772238PULSE GENERATOR, UNIPOLAR, PROGRAMABLE3Cleared 510(K)
- K772241PULSE GENERATOR, BIPOLAR, DEMAND3Cleared 510(K)
- K772239PULSE GENERATOR, BIPOLAR, PROGRAMMABLE3Cleared 510(K)
- K772051MDL-2013Cleared 510(K)
- K772050TDL-100 B3Cleared 510(K)
- K780061PULSE GENERATORS, MODELS 5972/59733Cleared 510(K)
- K772357PULSE GENERATORS3Cleared 510(K)
- K771786CARDIAC PULSE GENERATORS 5982/59833Cleared 510(K)
- K771770XYREL-RA MODELS 5994/59953Cleared 510(K)
- K772202PULSE GENERATOR, A-V SEQ.3Cleared 510(K)
- K772010CARDIAC PACEMAKER C20013Cleared 510(K)
- K772009CARDIAC PACEMAKER S60013Cleared 510(K)
- K772057BIPOLAR PACEMAKER MODEL 2243Cleared 510(K)
- K772026CARDIAC PULSE GENERATOR, MODEL 150L3Cleared 510(K)
- K771992L-501 CARDIAC PACEMAKER3Cleared 510(K)
- K771987MICROPULSE 26U PULSE GENERATOR3Cleared 510(K)
- K771670IMPLANTED PACEMAKER PLUSE GENERATOR3Cleared 510(K)
- K771626PACEMAKER MODEL 2513Cleared 510(K)
- K771538LITHICRON MODEL 3-70C-B PULSE GENERATOR3Cleared 510(K)
- K771262PACEMAKER & CARDIAC LEAD, BIPOLAR3Cleared 510(K)
- K770951CARDIAC PACERS W/NARROW PULSE WIDTH3Cleared 510(K)
- K770880GENERATOR, PULSE, UNIPOLAR, #5083Cleared 510(K)
- K770881GENERATOR, PULSE, BIPOLAR 36083Cleared 510(K)
- K770716GENERATOR, PULSE, UNIPOLAR, MODEL #5043Cleared 510(K)
- K770661GENERATOR, PULSE, IMPLANTABLE3Cleared 510(K)
- K770656GENERATOR, PULSE, CARDIAC 20U3Cleared 510(K)
- K770657GENERATOR, PULSE, CARDIAC 2LU3Cleared 510(K)
- K770715GENERATOR, PULSE, BIPOLAR, MODEL #6043Cleared 510(K)
- K770507PULSE GENERATOR, LITKICRON MODEL 3-70H3Cleared 510(K)
- K770419CENTURION3Cleared 510(K)
- K770559C-L0L CARDIAC PACEMAKER3Cleared 510(K)
- K770212PROLITH MODEL 21S CARDIAC PULSE GEN.3Cleared 510(K)
- K770211MICROPULSE MODEL 20S3Cleared 510(K)
- K770328PACEMAKER, ANTRIO-VENTRICULAR SEQ.3Cleared 510(K)
- K770005PACEMAKER 208S3Cleared 510(K)
- K770198BIPOLAR ASYNCHRONOUS PULSE GENERATOR3Cleared 510(K)
- K770197UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR3Cleared 510(K)
- K770135LEAD MODIFICATION3Cleared 510(K)
- K761143LITHIUM IODIDE BATTERY PACEMAKER (#201)3Cleared 510(K)
- K761237ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-53Cleared 510(K)
- K760669PACEMAKERS, VITATRON'S3Cleared 510(K)
- K760670PACEMAKERS, VITATRONS (SERIES 2000)3Cleared 510(K)
- K760671PACEMAKERS, VITATRONS (SERIES 3000)3Cleared 510(K)
- K760757MODEL 100 CARDIAC PACEMAKER3Cleared 510(K)
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2Product Code
- DYEReplacement Heart-Valve3Product Code
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter2Product Code
- KFJMaterials, Repair Or Replacement, Pacemaker3Product Code
- KRDDevice, Vascular, For Promoting Embolization2Product Code
- KREAnalyzer, Pacemaker Generator Function, Indirect2Product Code
- KRFCharger, Pacemaker1Product Code
- KRGProgrammer, Pacemaker3Product Code
- KRHRing, Annuloplasty2Product Code
- LDFElectrode, Pacemaker, Temporary2Product Code
- MABMarker, Cardiopulmonary Bypass (Vein Marker)2Product Code
- MALGraft, Vascular, Synthetic/Biologic Composite2Product Code
- MFXVessel Guard Or Cover, To Facilitate Revision Surgeries2Product Code
- MOPRotator, Prosthetic Heart Valve1Product Code
- MZYGraft, Vascular, Stainless Steel Tunneler2Product Code
- NHWElectrode, Pacing And Cardioversion, Temporary, Epicardial2Product Code
- NKOSystem, Balloon, Intra-Aortic And Control, Reprocessed3Product Code
- OKRVentricular Bypass (Assist) Device3Product Code
- OMHPericardial Patch To Facilitate Revision Surgeries2Product Code
- OMRVessel Guard Or Cover2Product Code
- OTDEndovascular Suturing System2Product Code
- OVJPulse Generator, External Pacemaker, Dual Chamber2Product Code
- PALPulmonic Replacement Heart ValveFProduct Code
- PCKPediatric Ventricular Assist DeviceFProduct Code
- PNJLeadless Pacemaker3Product Code
- PNSShort-Term Intravascular Filter Catheter2Product Code
- PSQIntracardiac Patch Or Pledget, Biologically Derived2Product Code
- PSTAortic Annuloplasty Ring2Product Code
- QABPacing System Analyzer2Product Code
- 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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OPUS MODEL 4001
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K894065
- 510(k) Type
- Traditional
- Applicant
- ELA MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/26/1989
- Days to Decision
- 110 days