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
- 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
- PIZCombination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve3Product Code
- 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
- QYUInfant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use2Product Code
- 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
- SGOPercutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures2Product Code
- Submissions with No Product CodeMiscellaneous
- K243598Welch Allyn Connex® 360 (Multiple)Cleared 510(K)
- P980017PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20APWDPMA Approval
- K871408BLOOD VESSEL CONNECTORCleared 510(K)
- K870477DEVICE CONNECTORS #000299-000 3/8 X 3/8 X 3/8 YCleared 510(K)
- K870418MYA-1 AND MYT-1 MYELOGRAM TRAYCleared 510(K)
- K865090PREGELLED DISPOS. ELECTRODE,SILVER-SILVER CHLORIDECleared 510(K)
- K863608DATASCOPE BALLOON DILATATION CATHETERCleared 510(K)
- K864682SALT CREEK P.I. TRAYCleared 510(K)
- K864637MODIFIED ESCHMANN DILATATION CATHETERCleared 510(K)
- K863716RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTERCleared 510(K)
- P030054Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra AssOK30PMA Approval
- P140033Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRIOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROCETA XT CRT-D, VIVA QUAD S CRT-D, VIVA QUARD XT CRT-DOK30PMA Approval
- P010031Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Concerto II CRT-D D274TRK; Consulta CRT-D D204TRM, D224OK30PMA Approval
- P010031Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRTD DTBC1Q1, DTBC1QQ; Concerto II CRTD, D274TRK; Consulta CRT-D D204TRM, D224TOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D , PROTECTA CRT-D, PROTOK30PMA Approval
- P010012DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-DOK30PMA Approval
- P010012DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D, ORIGEN CRT-D & X4 CRT-DOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D; PROTECTA CRT-D, PROTECTA XT CRT-D,OK30PMA Approval
- P010031BRAVA CRT-D,BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D, EVERA MRI ICDOK30PMA Approval
- P010031BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D,OK30PMA Approval
- P010031BRAVA CRT-D,BRAVA QUARD CRT-D,CONCERTO II CRT-D, CONSULTA CRT-D,MAXIMOII CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVAOK30PMA Approval
- P010012PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNHRONIZATION THERAPY-DEFIBRILLATOROK30PMA Approval
- P010012ORIGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4 CRT-D; DYNAGEN CRT-D, X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORSOK30PMA Approval
- P010012INCEPTA CRT D, ENERGEN CRT D, PUNCTUA CRT-D, DYNAGEN CRT-D, INOGEN CRT D, ORIGEN CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D,OK30PMA Approval
- P010012DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, ORIGEN CRT-D, X4 CRT-D, INCEPTA TM ICD, ENERGEN TM ICD & PUNCTUA TM ICDOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA CRT-D, VIVAOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D; PROTECTA CRT-D,PROTECTA XT CRT-D, VIVOK30PMA Approval
- P010012INCEPTA, ENERGEN, PUNCTUA, DYNAGEN,INOGEN,ORIGEN CRT-DOK30PMA Approval
- P010012DYNAGEN, INOGEN, ORIGEN, CRT-D DEVICESOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010012EASYTRAK 2 CORONARY SINUS PACING LEADS, EASYTRAK 3 CORONARY SINUS PACING LEADS, ACUITY SPIRAL CORONARY SINUS PACING LEADOK30PMA Approval
- P010012EASYTRAK 2 AND EASYTRAK 3 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD,ACUITY SPIRAL LEADOK30PMA Approval
- P010031BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD, VIVA S/XT CRT-D'SOK30PMA Approval
- P010012DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA ICD'SOK30PMA Approval
- P010012DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM IOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC MAXIMO ICD, MAXIMO II CRT-D, PROTECTA CRT-D,OK30PMA Approval
- P010012INOGEN, ORIGEN AND DYNAGEN CRT-D'SOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA , BRAVA QUAD/S , VIVA QUAD S/XT ,, VIVA S/XT CRT-D'SOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-DOK30PMA Approval
- P010031BRAVA (CRT-D/QUAD),CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D,PROTECTA XT,VIVA QUAD (S/XT),VIVA (S/XT)OK30PMA Approval
- P010031BRAVA,BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT CROK30PMA Approval
- P010031BRAVA, BRAVA QUAD, VIVA QUAD, VIVA QUAD S, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CROK30PMA Approval
- P010012INOGEN, ORIGEN AND DYNAGEN CRT-DSOK30PMA Approval
- P010031BRAVA CRT-D; BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTCA CRT-D & XT CRT-D, VIVA QUADOK30PMA Approval
- P010031BRAVA , QUAD , VIVA QUAD S CRT-D'S; VIVA QUAD S , QUAD XT, S VIVA S CRT-D'SOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD SOK30PMA Approval
- P010012DYNAGEN,INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR,OK30PMA Approval
- P010031BRAVA- BRAVA QUAD , CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT,VIVA QUAD, QUAD S AND IX CRT-D'SOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD SOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D'S; BRAVA QUAD CRT-D'S; CONCERTO II CRT-D; CONSULTA CRT-D; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRTOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUARD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUADOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D,OK30PMA Approval
- P010012CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)OK30PMA Approval
- P010012DYNAGEN, INOGEN, ORIGEN CRT-DSOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D AND VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D,OK30PMA Approval
- P010012ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DSOK30PMA Approval
- P010031CONCERTO II,CONSULTA,MAXIMO II,PROTECTA AND PROTECTA XT CRT-DSOK30PMA Approval
- P010012ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DSOK30PMA Approval
- P010031BRAVA CRT-D'S BRAVA QUAD CRT-D'S, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-DOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D, EVERA S DR ICDOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D,OK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D, PROTECTA XT CRTOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUADA CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA & QUAD CRT-DS, VIVA QUAD S & XT CRT-DS, VIVA S & XT CRT-DSOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROCTECTA CRT-D,PROTECTA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVAOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVAOK30PMA Approval
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVAOK30PMA Approval
- P010031BRAVA QUAD CRT-D, VIVA QUAD C CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA QUAD CRT-D, VIVA QUAD C CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-DOK30PMA Approval
- P010031BRAVA/ BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT ,VIVA QUAD S/XT/S CRT-D'SOK30PMA Approval
- P010031CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, & PROTECTA XT CRT-D'SOK30PMA Approval
- P010031INSYNCC III MARQUIS ICD, INSYNC MAXIMO ICDOK30PMA Approval
- P010031BRAVA CRT-D; CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D , PROTECTA CRT-D,PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XTOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, CONCETO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA S CRT-D, XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D ; CONCERTO II CRT-D; CONSULTA ICD; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT-D; VIVA S CRT-D; XT CRT-OK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031BRAVACRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031CONSULTA CRT-D, MAXIMO II CRT-D, CONCERTO 11 CRT-D, CPMCERTP CRT-DAPPRPMA Approval
- P010031BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XTOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DAPPRPMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-DOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D AND PROTECTA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA S CRT-D, XTCRT-DOK30PMA Approval
- P010031BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D VIVA S CRT-D, VIVA XT CRTOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, CONCERTA II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA/PROTECTA XT CRT-D S/VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D; CONCERTO II CRT-D; CONSULTA ICD,MAXIMO II CRT-D, PROTECTA XI C RT-D, VIVA S/X CRT-D;OK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D,& XT CRT-D, BRAVA CRT-D, VIVA S CRT-DAPPRPMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA C RT-D; VIVA S CRT-D; VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-DAND VIVA XT- CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,CONCERTO II CRT-D, CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, CONCERTO II CRT-D, COSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D, PROTECTA CRT-DOK30PMA Approval
- P010031BRAVA,VIVA S,VIVA XT CRT-DSOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031CONSULTA ICD & BRAVA, CONCERTO II, MAXIMO II,PROTECTA/PROTECTA XT, VIVA S/XT CRT- D'SOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA ICD, MAXIMO CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTOK30PMA Approval
- P010031BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D/ XT CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-DOK30PMA Approval
- P010031BRAVA,CONCERTO II,MAXIMO II,PROTECTA,PROTECTA XT,VIVA S,VIVA XT CRTS,CONSULTA ICDOK30PMA Approval
- P010031BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,VIVA SOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXOK30PMA Approval
- P010031BRAVA CRT-D, CONCERTOII CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XTOK30PMA Approval
- P010031BRAVA CRT-P,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, CONCENTOIICRT-D, CONSULTA ICD,MAXIMOII CRT,PROTECTA CRT-D, PROTECAXT CRT-D,VIVA S CRT-D,VIVAXT CRT-DOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031CONSULTA DF4 ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031BRAVIA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-DOK30PMA Approval
- P010031BLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM)OK30PMA Approval
- P010031BRAVA/VIVA S/VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-DOK30PMA Approval
- P010031D286 CURRENT DRAIN LIMITSOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P010031BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-DOK30PMA Approval
- P950020CORONARY FLEXTONE CUTTING BALLOONOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031CONCERTO ICD, CONCERTO II CRT-D & DF4 ICD, CONSULTA ICD, INSYNC II MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-DOK30PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLONOK30PMA Approval
- P950020FLEXTOME CUTTING BALLOON DILATATION DEVICEOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF4 CRT-D, PROTECTA CRT-D, PROTECTA DF4 CROK30PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLOONOK30PMA Approval
- P010031CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-DOK30PMA Approval
- P010031CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D. PROTECTA XT CRT-DOK30PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLOONOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P950020FLEXTOME CUTTING BALLOON DILATATION DEVICE (MONORAIL & OVER-THE-WIRE)OK30PMA Approval
- P010031PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031CONCERTO II CRT-D. CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF-4 CRT-D, PROTECTA CRT-D, PROTECTA DF4OK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P950020FLEXTOME CUTTING BALLOONOK30PMA Approval
- P950020FLEXTOME CUTTING BALLOON DILATATION DEVICEOK30PMA Approval
- P010031CONCERTO II, CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031PROTECTA CRT-D, D334TRG, D334TRM, PROTECTA XT CRT-D, D314TRG, D314TRMOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD AND MAXIMO II CRT-DOK30PMA Approval
- P010031CONCERTO ICD, CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO II CRT-D, PROTECTOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031CONCERTO ICD, CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II DFOK30PMA Approval
- P010031CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD,CONSULTA, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D,OK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-DOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-DOK30PMA Approval
- P010031MAXIMO II DF-4, MAXIMO II, DF-4, PROTECTA DF-4, PROTECTA ICD, PROTECTA XT DF-4, PROTECTA XT ICD, SECURA DF-4, SECURA ICOK30PMA Approval
- P950020FLEXTOME CUTTING BALLOON (MONORAIL)OK30PMA Approval
- P010031PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D ICDSOK30PMA Approval
- P010031PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-DOK30PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLOONOK30PMA Approval
- P010031PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-DOK30PMA Approval
- P010031CONSULTA, MAXIMO II, PROTECTA, PROTECTA XTOK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D/DF4, PROTECTA CRT-D/DF4/XT CRT-D/XT DF4OK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA & DF4, MAXIMO II CRT-D & DF4, PROTECTA CRT-D & DF4 & XT CRT-D & XT DF4OK30PMA Approval
- P010031CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4OK30PMA Approval
- P010031MAXIMO II ICD, MAXIMO II M4, PROTECTA ICD, PROTECTA M4, XT ICD, PROTECTA XT M4, SECURA ICD, SECURA M4, VIRTUOSO II DR/VROK30PMA Approval
- P010031CONSULTA II CRT-D, CONSULTA, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA, PROTECTA XTOK30PMA Approval
- P910020RELAYOK30PMA Approval
- P010031INSYNC ICD MODEL 7272OK30PMA Approval
- P010031INSYNC ICD MODEL 7272OK30PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLOONOK30PMA Approval
- P010031INSYNC ICD MODEL 7272OK30PMA Approval
- P010031PROTECTA CRT-D, PROTECTA XT CRT-DOK30PMA Approval
- P010031INSYNC III MARQUIS & INSYNC MAXIMO ICDSOK30PMA Approval
- P010031MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM)OK30PMA Approval
- P010031MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM)OK30PMA Approval
- P010031INSYNC III MARQUIS & INSYNC MAXIMO ICDSOK30PMA Approval
- P010031INSYNC/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA/PROTECTA XT/PROTECTA/PROTECTA DF4OK30PMA Approval
- P010031CONCERTO/CONCERTO II, CONSULTA, MAXIMO II, PROTECTA/PROTECTA XTOK30PMA Approval
- P010031PROTECTA & PROTECTA XTOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XTOK30PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLOONOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XTOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO II/PROTECCTA/PROTECTA XTOK30PMA Approval
- P010031CONCERTO/CONCERTO II/CONSULTA/INSYNC II & III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO PROTECTA/PROTECTA XTOK30PMA Approval
- P010031PROTECTA/PROTECTA XTOK30PMA Approval
- P010031CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XTOK30PMA Approval
- P010031(D334TRG), PROTECTA XT (D314TRG)OK30PMA Approval
- P010031CONCERTO/CONCERTO II, CONSULTA, VARIOUS INSYNC MODELS, MAXIMO II, PROTECTA/PROTECTA XTOK30PMA Approval
- P010031CONCERTO/CONCERTOI II. CONSULTA, VARIOUS INSYNC MODELS, MAXIMO II, PROTECTA/PROTECTS XTOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO IIOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO IIOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO IIOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO IIOK30PMA Approval
- P950020CUTTING BALLOON ULTRA 2 MONORAIL AND FLEXTOME CUTTING BALLOON MONORAILOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO IIOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO IIOK30PMA Approval
- P950020CORONARY FLEXTOME CUTTING BALLOONOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO IIOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO IIOK30PMA Approval
- P010031CONCERTO/CONCERTO II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XTOK30PMA Approval
- P010031PROTECTA/PROTECTA XT CRT-DOK30PMA Approval
- P950020FLEXTOME CUTTING BALLOON DILATATION DEVICEOK30PMA Approval
- P010031PROTECTA/PROTECTA XT CRT-DOK30PMA Approval
- P010031CONCERTO/CONCERTO II/CONSULTA/DF4/INSYNC II/III/MAXIMO/SENTRY/MAXIMO II/II M4/PROTECTA XT/PROTECTA/PROTECTA XT M4/M4OK30PMA Approval
- P010031CONCERTO ICD/CONSULTA/CONCERTO II/MAXIMO II CRT-D/INSYNC II/III MARQUIS/MARQUIS DR/INSYNC MARQUIS/MAXIMO/SENTRYOK30PMA Approval
- P010031INSYNC SENTRY CRT-D/CONCERTO ICD/CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO II CRT-D/PROTECTA/XT CRT-DOK30PMA Approval
- P010031PROTECTA/PROTECTA XT CRT-DSOK30PMA Approval
- P010031CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XTOK30PMA Approval
- P010031PROTECTA & PROTECTA XT CRT-DSOK30PMA Approval
- P010031PROTECTA/PROTECTA XT CRT-DOK30PMA Approval
- P010031PROTECTA/PROTECTA XT CRT-DSOK30PMA Approval
- P010031PROTECTA XT/PROTECTA DEVICESOK30PMA Approval
- P010031PROTECTA/PROTECTA XT CRT-DSOK30PMA Approval
- P010031PROTECTA CRT-D/PROTECTA XT CRT-DOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO II CRT-DSOK30PMA Approval
- P010031CONCERTO II ICD/CONSULTA/MAXIMO II CRT-DSOK30PMA Approval
- P010031INSYNC SENTRY CRT-D/CONCERTO ICD/CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO II CRT-DOK30PMA Approval
- P010031CONCERTO/II ICD/CONSULTA CRT-D/MAXIMO II CRT-DOK30PMA Approval
- P010031CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-DOK30PMA Approval
- P010031CONCERTO/CONCERTO II/CONSULTA/INSYNC II MARQUIS/INSYNC III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO IIOK30PMA Approval
- P010031CONCERTO CRT-D/CONCERTO II ICD/CONSULTA CRT-D/INSYNC II MARQUIS/PROTECT/INSYNC III MARQUIS/INSYNC MARQUIS/INSYNC MAXIMOOK30PMA Approval
- P010031CONCERTO II/MAXIMO II/CONSULTA/CONCERTO CRT-DS/INSYNC MAXIMO/SENTRY/INSYNC II MARQUIS/INSYNC III MARQUIS ICDSOK30PMA Approval
- P010031CONCERTO II/MAXIMO II/CONSULTA CRT-DSOK30PMA Approval
- P010031CONSULTA/CONSULTA II/MAXIMO II/CONCERTO CRT-DSOK30PMA Approval
- P010031CONCERTO II/MAXIMO II/CONSULTA CRT-DSOK30PMA Approval
- P010031CONCERTO II/MAXIMO II/CONSULTA CRT-DSOK30PMA Approval
- P010031CONCERTO II/CONSULTA /MAXIMO II CRT-DSOK30PMA Approval
- P010031INSYNC/INSYNC MARQUIS/INSYNC II/III MARQUIS/INSYNC II PROTECT/SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DSOK30PMA Approval
- P010031INSYNC MARQUIS ICDOK30PMA Approval
- P010031CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-DOK30PMA Approval
- P010031INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/II/CONCERTO/II/CONSULTAOK30PMA Approval
- P010031INSYNC III/II MARQUIS CRT-D/INSYNC SENTRY/MAXIMO CRT-D/CONCERTO/CONSULTA/CONCERTO II/MAXIMO II CRT-DOK30PMA Approval
- P010031CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTOOK30PMA Approval
- P010031CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTOOK30PMA Approval
- P010031CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTOOK30PMA Approval
- P010031INSYNC III/II MARQUIS/INSYNC SENTRY/MAXIMO ICDSOK30PMA Approval
- P010031INSYNC/INSYNC MARQUIS/II/III/INSYNC II PROTECT/SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DSOK30PMA Approval
- P010031CONCERTO/CONSULTA/MAXIMO II/ CONCERTO II CRT-DSOK30PMA Approval
- P010031INSYNC SENTRY/III MARQUIS/II MARQUIS/MAXIMO/CONCERTO ICDS/CONSULTA/MAXIMO II/CONCERTO II CRT-DSOK30PMA Approval
- P010031CONCERTO/II/CONSULTA/INSYNC ICD/MARQUIS/MAXIMO/II MARQUIS/MAXIMO II/II PROTECT/III MARQUIS/SENTRY/CONEXUS ACTIVATOROK30PMA Approval
- P010031INSYNC SENTRY & INSYNC MAXIMOOK30PMA Approval
- P010031CONCERTO/CONSULTA & MAXIMO II CRT-DSOK30PMA Approval
- P010031CONCERTO/CONCERTO II/CONSULTA/MAXIMO II CRT-DSOK30PMA Approval
- P010031CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-DOK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO II CRT-DS/CONCERTOOK30PMA Approval
- P010031CONCERTO/CONSULTA CRT-DS/CONCERTO II ICD/MAXIMO II CRT-DOK30PMA Approval
- P010031INSYNC ICD MODEL 7272OK30PMA Approval
- P010031CONCERTO II/CONSULTA/MAXIMO II CRT-DSOK30PMA Approval
- P010031INSYNC/MARQUIS/II & III MARQUIS/II PROTECT/SENTRY/MAXIMO ICDS & CONCERTO/CONCERTO II/MAXIMO II/CONSULTA CRT-DSOK30PMA Approval
- P010031INSYNC ICDOK30PMA Approval
- P010031CONCERTO II/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO CRT-DOK30PMA Approval
- P010031CONCERTO/II/CONSULTA/INSYNC ICD/MARQUIS/MAXIMO/INSYNC II/MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRYOK30PMA Approval
- P010031INSYNC III MARQUIS/PROTECT/INSYNC SENTRY/MAXIMO ICD/CONCERTO/II/MAXIMO II/CONSULTA CRT-DOK30PMA Approval
- P010031INSYNC/INSYNC MARQUIS/INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II CRT-DOK30PMA Approval
- P010031CONSULTA/MAXIMO II/CONCERTO II CRT-DSOK30PMA Approval
- P010031INSYNC II PROTECT/SENTRY/MARQUIS/MAXIMO ICDS/CONCERTO/CONSULTA/MAXIMO II/CONCERTO II CRT-DSOK30PMA Approval
- P010031CONCERTO/II/CONSULTA/INSYNC II/III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO II CRT-DSOK30PMA Approval
- P010031CONCERTO CRT-DOK30PMA Approval
- P010031INSYNC/INSYNC MARQUIS/II/III/INSYNC II PROTECT/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO/CONSULTA CRT-DSOK30PMA Approval
- P010031ATTAIN SD LH LEAD/INSYNC SENTRY/INSYNC MAXIMOOK30PMA Approval
- P010031INSYNC ICD/MARQUIS/II MARQUIS/III MARQUIS/II PROTECT/III PROTECT/SENTRY/MAXIMOICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DSOK30PMA Approval
- P010031CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTOOK30PMA Approval
- P010031INSYNC/INSYNC MARQUIS II/III/INSYNC PROTECT II/III/INSYNC SENTRY & MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DSOK30PMA Approval
- P010031INSYNC/INSYNC II/INSYNC III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO & II/MAXIMO II/CONSULTAOK30PMA Approval
- P010031CONCERTO II/MAXIMO II/CONSULTA CRT-DSOK30PMA Approval
- P010031CONCERTO CRT ICD/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-DOK30PMA Approval
- P010031INSYNC/INSYNC MARQUIS/II/III/INSYNC PTOTECT II/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DOK30PMA Approval
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- P010031CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-DAPPRPMA Approval
- P010031INSYNC/INSYNC MARQUIS II/III/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO/CONCERTO/II CRT-D/MAXIMO II/CONSULTA CRT-DOK30PMA Approval
- P010031MAXIMO II CRT-D/CONSULTA CRT-D/CONCERTO II CRT-DOK30PMA Approval
- P010031INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/INSYNC MARQUIS ICDSAPPRPMA Approval
- P010031CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO IIOK30PMA Approval
- P010031INSYNC II/III MARQUIS ICDS/INSYNC II/III PROTECT ICDS/INTRINSIC ICDOK30PMA Approval
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- P010031INSYNC FAMILIES OF ICDS/CONCERTO/MAXIMO II/CONSULTA FAMILIES OF CRT-DSAPPRPMA Approval
- P010031INSYNC II/III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/CONCERTO/MAXIMO II/CONSULTA/CONCERTO II CRT-DSOK30PMA Approval
- P010031INSYNC FAMILY OF ICDS/CONCERTO/MAXIMO II CRT-D/CONSULTA CRT-DOK30PMA Approval
- P010031INSYNC/CONCERTO/MAXIMO/CONSULTA FAMILIES OF ICDS & CRT-DSAPPRPMA Approval
- P010031INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/MAXIMO II/CONSULTA/CONCERTO II CRTOK30PMA Approval
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- P010031CONSULTA/MAXIMO II/CONCERTO II CRT-DSAPPRPMA Approval
- P010031INSYNC II/III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-DOK30PMA Approval
- P010031INSYNC FAMILIES OF ICDS/CONSULTA CRT-D/CONCERTO ICD/MAXIMO II CRT-D/CONCERTO II CRT-DOK30PMA Approval
- P010031INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILIES OF ICDSAPPRPMA Approval
- P010031CONCERTO CRT-DAPPRPMA Approval
- P010031CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-DOK30PMA Approval
- P010031CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO IIOK30PMA Approval
- P010031CONCERTO ICRT-DOK30PMA Approval
- P010031CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-DAPPRPMA Approval
- P010031CONCERTOAPPRPMA Approval
- P010031CONCERTO CRT-DOK30PMA Approval
- P010031MAXIMO II CRT-D/CONCERTO ICD/CONSULTA CRT-D/INSYNC III MARQUIS/PROTECT/INSYNC SENTRY ICD/CONCERTO II CRT-DOK30PMA Approval
- P010031ATTAIN SDOK30PMA Approval
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- P010031INSYNC SENTRY/MAXIMO CRT-D/INSYNC II PROTECT & MARQUIS/CONCERTO ICDOK30PMA Approval
- P010031INSYNC FAMILIES OF ICDS/CONCERTO CRT-D/MAXIMO II/CONSULTA/CONCERTO II CRT-DOK30PMA Approval
- P010031CONCERTO CRT-DOK30PMA Approval
- P010031INSYNC FAMILIES OF ICD & CONCERTO ICDOK30PMA Approval
- P010031CONSULTA CRT-D & MAXIMO II CRT-DOK30PMA Approval
- P010031CONCERTO/CONSULTA/MAXIMO IIOK30PMA Approval
- P010031VARIOUS FAMILIES OF CRT-ICDSOK30PMA Approval
- P010031INSYNCII/ III PROTECT/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/CONCERTO/MAXIMO IIOK30PMA Approval
- P010031INSYNC FAMILIES OF ICDSOK30PMA Approval
- P010031CONCERTO/MAXIMO II/CONSULTAOK30PMA Approval
- P010031INSYNC CRT-D/CONCERTO/CONSULTA/MAXIMO II & VARIOUS INSYNC FAMILIES OF ICDSOK30PMA Approval
- P010031MAXIMO II CRT-DOK30PMA Approval
- P010031INSYNC SENTRY FAMILY/INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC MAXIMO FAMILY/CONCERTOOK30PMA Approval
- P010031CONSULTA CRT-D & MAXIMO II CRT-DOK30PMA Approval
- P010031CONCERTOOK30PMA Approval
- P010031CONSULTA CRT-D & MAXIMO II CRT-DOK30PMA Approval
- P010031CONSULTA CRT-D & MAXIMO II CRT-DOK30PMA Approval
- P010031CONCERTOOK30PMA Approval
- P010031CONSULTA CRT-D & MAXIMO II CRT-DOK30PMA Approval
- P010031CONCERTO, CONSULTA CRT-D & MAXIMO II CRT-DOK30PMA Approval
- P010031CONSULTA CRT & MAXIMO II CRTOK30PMA Approval
- P010031ATTAIN SDOK30PMA Approval
- P010031INSYNC ICD & INSYNC MARQUIS, INSYNC II & III MARQUIS FAMILY & INSYNC II PROTECT & INSYNC SENTRY & MAXIMO FAMILYOK30PMA Approval
- P010031CONCERTOOK30PMA Approval
- P010031INSYNC MARQUIS, INSYNC 2 & 3 MARQUIS, INSYNC 2 &3 PROTECT INSYNC SENTRY FAMILY, INSYNC MAXIMO FAMILY, CONCERTOOK30PMA Approval
- P010031ENRHYTHMOK30PMA Approval
- P010031CONCERTOOK30PMA Approval
- P010031INSYNC FAMILIES OF ICD & CONCERTO ICDOK30PMA Approval
- P980016GEM DR, GEM II VR, GEM II DR, AND GEM III IMPLANTABLE CARDIOVERTER DEFIBRILLATORSOK30PMA Approval
- P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORSOK30PMA Approval
- P980001NIR STENT DELIVERY SYSTEMSOK30PMA Approval
- P980001NIR PREMOUNTED STENT DELIVERY SYSTEMSAPPRPMA Approval
- P980016MEDTRONIC GEM DR MODEL 7271APPRPMA Approval
- P980035MEDTRONIC SIGMA/MEDTRONIC 350 SERIES PULSE GENERATORS PRODUCTSAPPRPMA Approval
- P980001NIR PREMOUNTED STENT SYSTEMSOK30PMA Approval
- P980001NIR CORONARY STENT WITH DELIVERY SYSTEMAPPRPMA Approval
- P970061RADIUS CORONARY STENT WITH DELIVERY SYSTEMAPPRPMA Approval
- P980016GEM DR/GEM II DR/GEM II VROK30PMA Approval
- P990037VASCULAR SOLUTIONS DUETT SEALING DEVICEAPPRPMA Approval
- P980001NIR(R) PREMOUNTED STENT SYSTEMOK30PMA Approval
- P990064MEDTRONIC MOSAIC PORCINE BIOPROSTHESES MODEL 305 (AORTIC) AND MODEL 310 (MITRAL)APPRPMA Approval
- P980001NIR PREMOUNTED STENT SYSTEMSAPPRPMA Approval
- P980016MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276APPRPMA Approval
- P980016GEM DR/GEM II DR/GEM II VRAPPRPMA Approval
- P980035MEDTRONIC KAPPA 700/600 PULSE GENERATORAPPRPMA Approval
- P940008INTERMEDICS MICRON IMPLANTABLE DEFIBRILLATORSAPPRPMA Approval
- P920047EPT-1000 CARDIAC ABLATION SYSTEMOK30PMA Approval
- P980001NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEMOK30PMA Approval
- P980001NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEMOK30PMA Approval
- P970061RADIUS(TM) CORONARY STENT WITH DELIVERY SYSTEMOK30PMA Approval
- P980001NIR(R) PREMOUNTED STENT DELIVERY SYSTEMSOK30PMA Approval
- P990037VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICEAPPRPMA Approval
- P980016MEDTRONIC VISION SOFTWARE SERIES 4.0APPRPMA Approval
- P990037VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICEAPPRPMA Approval
- P980035MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953 - SERIES 1.1 SOFTWAREAPPRPMA Approval
- P980016SMARTMAGNET(TM)APPRPMA Approval
- P980001NIR PREMOUNTED STENT SYSTEMSOK30PMA Approval
- P980001NIR ELITE MONORAIL AND OVER-THE-WIRE(OTW) STENT SYSTEMSAPPRPMA Approval
- P980001NIROYAL(TM) ELITE OVER-THE-WIRE(OTW) STENT SYSTEMAPPRPMA Approval
- P980001NIROYAL(R) ELITE PREMOUNTED STENT SYSTEMAPPRPMA Approval
- P960042LASER SHEATHAPPRPMA Approval
- P980001NIR PREMOUNTED STENT DELIVERY SYSTEMSOK30PMA Approval
- P960043THE CLOSER(TM) AND THE CLOSER S(TM) DEVICESOK30PMA Approval
- P980016GEM III VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD)APPRPMA Approval
- P980016GEM II MODEL 7273/GEM DR 7271/GEM II VR 7229 ICDSAPPRPMA Approval
- P980016MEDTRONIC GEMIII DR MODEL 7275 (ICD), MODEL 9970 PROGRAMMER APPLICATION SOFTWAREAPPRPMA Approval
- P980049ORCHESTRA PROGRAMMERAPPRPMA Approval
- P980001NIR(TM) PREMOUNTED STENT SYSTEMSOK30PMA Approval
- P960043KNOT PUSHER WITH TRIMMER(TM)APPRPMA Approval
- P980001NIR PREMOUNTED STENT SYSTEMSOK30PMA Approval
- P980035MEDTRONIC SIGMA SERIES PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEMAPPRPMA Approval
- P940008LEAD CAP ACCESSORY KITAPPRPMA Approval
- P960043CLOSER S(TM) 6FR. SMC DEVICEAPPRPMA Approval
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- P990064MOSAIC PORCINE BIOPROSTHESISOK30PMA Approval
- P970061BOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENTAPPRPMA Approval
- P960043CLOSER (TM) SUTURE MEDIATED CLOSURE DEVICEAPPRPMA Approval
- P980001NIROYAL(TM1) ELITE PREMOUNTED STENT SYSTEMAPPRPMA Approval
- P980001NIR(R) PREMOUNTER STENT SYSTEMSAPPRPMA Approval
- P980001NIROYAL(TM) ADVANCE PREMOUNTED STENT SYSTEMAPPRPMA Approval
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- P980001NIR (TM) W/SOX PREMOUNTED STENT DELIVERY SYSTEMOK30PMA Approval
- P980001NIR W/SOX PREMOUNTED STENT DELIVERY SYSTEMOK30PMA Approval
- P980001NIROYAL ADVANCE PREMOUNTED STENT SYSTEMAPPRPMA Approval
- P960043CLOSER 6 FR. SUTURE MEDIATED CLOSURE DEVICEAPPRPMA Approval
- P960043CLOSER SUTURE MEDIATED CLOSURE DEVICE & ACCESSORIESAPPRPMA Approval
- P960043CLOSER 6 FR. SUTURE-MEDIATED CLOSURE DEVICEAPPRPMA Approval
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- P980035KAPPA 706 SR IPGAPPRPMA Approval
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- P990017EVT ABDOMINAL AORTIC TUBE/EVT ABDOMINAL AORTIC BIFAPPRPMA Approval
- P980001NIR PREMOUNTED STENT SYSTEMSAPPRPMA Approval
- P960042SPECTRANETICS LASER SHEATHS (SLS)APPRPMA Approval
- P980001NIR W/SOX PREMOUNTED STENT SYSTEMAPPRPMA Approval
- P960043CLOSER SUTURE MEDIATED CLOSURE DEVICE & ACCESSORIESAPPRPMA Approval
- P980001NIR(TM) PREMOUNTED STENT SYSTEMSOK30PMA Approval
- P970061RADIUS CORONARY STENT WITH DELIVERY SYSTEMAPPRPMA Approval
- P990017ANCURE TUBE AND BIFURCATED ENDOVASCULAR SYSTEMSAPPRPMA Approval
- P990017ANCURE(TM) ENDOGRAFT(R) SYSTEMAPPRPMA Approval
- P980035MEDTRONIC KAPPA 400/DX2 AND KAPPA 700/600 PACEMAKERSAPPRPMA Approval
- P980016MODEL 7271 GEM DR ICDAPPRPMA Approval
- P980035MEDTRONIC.KAPPA 700/600 SERIES OF PACEMAKERSAPPRPMA Approval
- P980016GEM II IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR MODELS 7273 & 7229APPRPMA Approval
- P980035MEDTRONIC 350 SERIES PACING SYSTEMAPPRPMA Approval
- P940008IMPLANTABLE PACEMAKER LEADAPPRPMA Approval
- P920047EPT-1000 CARDIAC ABLATION SYSTEMOK30PMA Approval
- P960043CLOSER PERCUTANEOUS VASCULAR SURGERY DEVICEAPPRPMA Approval
- P980001NIR PRIMO PREMOUNTED STENT DELIVERY SYSTEMOK30PMA Approval
- P970061SCIMED RADIUS CORONARY STENTAPPRPMA Approval
- P960043TECHSTAR XL 6 FR. PERCUTANEOUS VASCULAR SURGICAL DEVICESAPPRPMA Approval
- P980016MODEL 7271 GEM DR ICDAPPRPMA Approval
- P980035MEDTRONIC SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWAREAPPRPMA Approval
- P960042SPECTRANETICS LASER SHEATH KITS, 14FR AND 16FRAPPRPMA Approval
- P980001NIR ON RANGER PREMOUNTED STENT SYSTEMSAPPRPMA Approval
- P980016MEDTRONIC GEM II VR MODEL 7229 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATORAPPRPMA Approval
- P980001NIR PREMOUNTED STENT SYSTEMSOK30PMA Approval
- P980001NIR PREMOUNTED STENT SYSTEMSAPPRPMA Approval
- P970061SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM/31MM RADIUS OTW & 31 MM RADIUS SOEAPPRPMA Approval
- P980016MEDTRONIC MODEL 7273 GEM II DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORAPPRPMA Approval
- P980035MEDTRONIC VISION SOFTWARE (MODEL 9953A)APPRPMA Approval
- P980001NIR PRIMO PREMOUNTED STENT SYSTEMAPPRPMA Approval
- P960043TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMAPPRPMA Approval
- P960043TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMAPPRPMA Approval
- P960043TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMAPPRPMA Approval
- P980001NIR PRIMO PREMOUNTED STENT SYSTEMAPPRPMA Approval
- P960043TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMAPPRPMA Approval
- P960043TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMSAPPRPMA Approval
- P960043PERCLOSE PROSTAR XL 8 & 10 FRENCH PVS SYSTEMAPPRPMA Approval
- P960040VENTAK VR OMDEL 1774/MODEL 1775 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH MODEL 2841 SOFTWARE APPLICATIONAPPRPMA Approval
- P970061SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEMAPPRPMA Approval
- P980016GEM II DR MODEL 7273APPRPMA Approval
- P960043TECHSTAR XL & PROSTAR XL PERCTANEOUS VASCULAR SURGICAL DEVICEAPPRPMA Approval
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- P980001NIR PREMOUNTED STENT SYSTEMAPPRPMA Approval
- P960043TECHSTAR/PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMSAPPRPMA Approval
- P970061SCIMED RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE DELIVERY SYSTEMAPPRPMA Approval
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- P970061SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEMAPPRPMA Approval
- P980016MEDTRONIC MODEL 7273 GEM II DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 9964 (GEM II DR) APAPPRPMA Approval
- P960040VENTAK AV AICD & VENTAK AV II DDD AICDAPPRPMA Approval
- P980016MODEL 7271 ICDAPPRPMA Approval
- P960043PROSTAR XL AND TECHSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMSAPPRPMA Approval
- P960043TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMSAPPRPMA Approval
- P960040VENTAK AV II/III DR AICD SYSTEMSAPPRPMA Approval
- P960040VENTAK AV AICD FAMILY SYSTEMSAPPRPMA Approval
- P960043TECHSTAR AND PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMSAPPRPMA Approval
- P980017PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20APWDPMA Approval
- P970061SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEMAPPRPMA Approval
- P96004214 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPEAPPRPMA Approval
- P960043PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEMAPPRPMA Approval
- P960040VENTAK AV III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATIONAPPRPMA Approval
- P970020ACS MULTI-LINK TM CORONARY STENT SYSTEM WITH THE 25MM STENT LENGTHAPPRPMA Approval
- P960043TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMSAPPRPMA Approval
- P960042SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATHAPPRPMA Approval
- P940031MERIDIAN AND DISCOVERY PACEMAKER SYSTEMSAPPRPMA Approval
- P960043PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEMAPPRPMA Approval
- P940008RES-Q(TM) MICRON ICD SYSTEMAPPRPMA Approval
- P960040VENTAK AV II DR AICDAPPRPMA Approval
- P960040VENTAK AV DDD FAMILY OF AICD SYSTEMSAPPRPMA Approval
- P940008RES-Q(TM) MICRON ICD SYSTEMAPPRPMA Approval
- P960043PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XLAPPRPMA Approval
- P960040VENTAK AV AICD TM SYSTEMAPPRPMA Approval
- P960040VENTAK AV DDD FAMILY OF AICD SYSTEMSAPPRPMA Approval
- P940008RES-Q(TM) MICRON ICD SYSTEMAPPRPMA Approval
- P960043PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XLAPPRPMA Approval
- P960043TECHSTAR (TM) 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMAPPRPMA Approval
- P940008RES-Q(TM) MICRON ICD SYSTEMAPPRPMA Approval
- P960040VENTAK AV AICD TM SYSTEMAPPRPMA Approval
- P940031VIGOR(R) DR/SR PACEMAKER SYSTEMAPPRPMA Approval
- P940008RES-Q(TM) MICRON ICD SYSTEMAPPRPMA Approval
- P940031VIGOR MODEL 2880 SOFTWARE APPLICATION (REV 3.0)APPRPMA Approval
- P940008RES-Q(TM) MICRON ICD SYSTEMAPPRPMA Approval
- P940031VIGOR(R) DR/SR PACEMAKER SYSTEMAPPRPMA Approval
- P940031VIGOR(TM) DR PACEMAKER SYSTEMAPPRPMA Approval
- P940031VIGOR(TM) DR PACEMAKER SYSTEMAPPRPMA Approval
- P940031VIGOR(TM) DR PACEMAKER SYSTEMAPPRPMA Approval
- P940008RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMSAPPRPMA Approval
- P940031VIGOR(TM) DR PACEMAKER SYSTEMAPPRPMA Approval
- P940031VIGOR DR PACEMAKER SYSTEM; VIGOR DR MODEL 1230APPRPMA Approval
- P940031VIGOR(TM) DR PACEMAKER SYSTEMAPPRPMA Approval
- P840029HEMASHIELD (R) MICROVEL (R) DOUBLE VELOURAPPRPMA Approval
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- K854843MA-1 VOLUME VENTIALTORCleared 510(K)
- K843717VIRATEK SMALL PARTICLE AEROSOL GENERATCleared 510(K)
- K854022LPA-1 PRESSURE MONITORCleared 510(K)
- K853667BRONCHIAL CYTOLOGY BRUSHCleared 510(K)
- K854036MANUAL VENTILATION ACCESSORYCleared 510(K)
- K854026VEDLAR VENTILATOR (MODIFICATION)Cleared 510(K)
- K851366COMPANION 2800 VOLUME VENTILATORCleared 510(K)
- K852108NEWPORT VENTILATOR MODEL E-100Cleared 510(K)
- K853428CPR PROMPTCleared 510(K)
- K850740SECHRIST VOLUME VENTILATOR MODIFICATIONCleared 510(K)
- K852504OHMEDA CPU MONITORCleared 510(K)
- K851851STERILE ENDOTRACHEAL BRUSHESCleared 510(K)
- K851695ULTRA-NEB 100 ULTRASONIC NEBULIZERCleared 510(K)
- K851920COMPRESSED AIR CONNECTOR DISPOSABLE CONNECTORCleared 510(K)
- K850320NEBULIZER TREATMENT KITCleared 510(K)
- K844610PERRY SUTURING SET W/ANESTHETICCleared 510(K)
- K844458ND:YAG LASER PULMONARY OBSTRUCTIONCleared 510(K)
- K843796STERILE WATERCleared 510(K)
- K843857TRANSFERSCREEN IICleared 510(K)
- K843586THORA-KLEX AUTOTRANSFUSION KITCleared 510(K)
- K843700ST-200A W/MAXIMAL VOLUNTARY VENTILLAT-Cleared 510(K)
- K843840N2 TESTCleared 510(K)
- K843228ND. YAG LASER FOR ENDOBRONCHIAL OBSTRUCCleared 510(K)
- K842670BIOLAS YAG 100Cleared 510(K)
- K843001COOK PACEMAKER CORP. 116 BIOPOLAR CARDICleared 510(K)
- K842843DRYDEN SCAVENGER INTERFACE SYSTEMCleared 510(K)
- K842456JET VENTILATION ADAPTORCleared 510(K)
- K841875HEART-CHECK ECG TRANSMITTERCleared 510(K)
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- K841571MAXI-MISER WATER TRANSFER SET 1021/1022Cleared 510(K)
- K841535TRIPLE LUMEN INFUSION CATHETER/ACCESSCleared 510(K)
- K841718FREKATHETER VENOUS CATHETERISATION SYSCleared 510(K)
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- K841383CSPI ROTARY SURGICAL ASPIRATORCleared 510(K)
- K841242CSPI PREMIUM SURGICAL ASPIRATORCleared 510(K)
- K842169FCP-11ECGCleared 510(K)
- K833686FILTECH TECHNETIUM-99MM RADIOPHARMACEUCleared 510(K)
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- K834472DESERET EPIDURAL CATHETERCleared 510(K)
- K832092ELECTROCARDIOGRAPH MACHINES, W/ANALYZCleared 510(K)
- K834128GLOBE RES-Q-FLOCleared 510(K)
- K832195LUNG POWERCleared 510(K)
- K822856VITALINE 2Cleared 510(K)
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- K822926MODEL LS-85 & MEDEL 1828 LINESCAN VISCOCleared 510(K)
- K822091SIEMENS SIRECUST SYSTEMCleared 510(K)
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- K821056FLOW DIRECTED THERMAL-DILUTION CATHETERCleared 510(K)
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- K813220REGU-VAC OXYGENATING SUCTION CATHETERCleared 510(K)
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- K792239ELA MEDICAL ANATEC HOLTER SCANNERCleared 510(K)
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- K781737EXTRACTOR, SABIAN FOREIGN BODYCleared 510(K)
- K781568PACEMAKER, MODEL 251-01Cleared 510(K)
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- K781021AIR BUBBLE DETECTORCleared 510(K)
- K780772BJORK-SHILEY CARDIAC HEART VALVECleared 510(K)
- K781219ECON-O2Cleared 510(K)
- K781111LEAD CONVERSION KIT, MODEL 341Cleared 510(K)
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- K760499REAGENT, PARTIAL THROMBOPLASTINCleared 510(K)
- K760776IMPEDANCE TESTER (MODEL 4390)Cleared 510(K)
- K760773IMPEDANCE TESTER (MODEL 4370)Cleared 510(K)
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- K760223SCANNER, ULTRASOUND BODY/HEARTCleared 510(K)
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- 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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OXYGEN SATURATION METER MODEL NO. SM-1
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K802847
- 510(k) Type
- Traditional
- Applicant
- BENTLEY LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/16/1980
- Days to Decision
- 34 days