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
- 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
- K933278INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-043Cleared 510(K)
- K884522MODEL 5650 OPTIMATE PERSONAL PROGRAMMER3Cleared 510(K)
- K880738MODEL 2331T PATIENT PROGRAMMER3Cleared 510(K)
- K882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 40043Cleared 510(K)
- K864712MODEL 1740 PERSONAL POCKET PROGRAMMER3Cleared 510(K)
- K871986MODEL 5600B PROGRAMMER, PACEMAKER3Cleared 510(K)
- K863046ULTRA SOFTWARE MODULE: MODEL 20163Cleared 510(K)
- K863045PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 65803Cleared 510(K)
- K860584SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN3Cleared 510(K)
- K860546DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.373Cleared 510(K)
- P010031BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D3PMA Approval
- P010031APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC3PMA Approval
- P010031BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE3PMA Approval
- P890003MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS3PMA Approval
- P880086VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 56103PMA Approval
- P880086AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P830045EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE3PMA Approval
- P830045VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR3PMA Approval
- P830045MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE3PMA Approval
- P830045ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE3PMA Approval
- P830045ADX PULSE GENERATOR3PMA Approval
- P830045IDENTITY 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
- P830045EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS3PMA Approval
- P830045IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A3PMA Approval
- P830045APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)3PMA Approval
- P900070APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)3PMA Approval
- P880086AV PLUS DX, MODEL 13683PMA Approval
- P830045MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE3PMA Approval
- P830045ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235)3PMA Approval
- P830045ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM3PMA Approval
- P830045IDENTITY PULSE GENERATOR MODEL DR 53703PMA Approval
- P880006REGENCY SC+ PULSE GENERATORS3PMA Approval
- P830045INTEGRITY AFX DR MODEL 53463PMA Approval
- P830045MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE3PMA Approval
- P830045INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE3PMA Approval
- P830045VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE3PMA Approval
- P830045INTEGRITY DR MODEL 5336/INTEGRITY SR MODEL 51363PMA Approval
- P830045VENTRITEX ICD'S3PMA Approval
- P830045INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL3PMA Approval
- P830045V1. 2A PROGRAMMER SOFTWARE3PMA Approval
- P900070TRILOGY/SOLUS II/PARAGON III/PHOENIX III3PMA Approval
- P880006V.1 2A PROGRAMMER SOFTWARE3PMA Approval
- P880006MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS3PMA Approval
- P830045MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS3PMA Approval
- P880006MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER3PMA Approval
- P830045MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER3PMA Approval
- P900070TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO3PMA Approval
- P830045TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO3PMA Approval
- P8300453500/3510 PROGRAMMER3PMA Approval
- P830045CARDIAC PACEMAKER PROGRAMMER & BASE STATION3PMA Approval
- P8800863500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.033PMA Approval
- P8300453500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.033PMA Approval
- P880086AFFINITY SR/DR3PMA Approval
- P880086AFFINITY DR & DC; ENTITY DR & DC3PMA Approval
- P830045MODEL 3510 PROGRAMMER/3303 SOFTWARE3PMA Approval
- P880086MODEL 3510 PROGRAMMER/ 3303 SOFTWARE3PMA Approval
- P910077MODEL 2901 PROGRAMMER3PMA Approval
- P940031MODEL 2901 PROGRAMMERR SYSTEM3PMA Approval
- K844484HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA3Cleared 510(K)
- K844483TP 13Cleared 510(K)
- K844485CERYX6, 611, CERYX 3 311 & CERYX 1 1113Cleared 510(K)
- K842364HANDHELD PACEMAKER PROGRAMMER & SOFTWAR3Cleared 510(K)
- K820230PACEMAKER PROGRAMMER 20303Cleared 510(K)
- K812761FLOW-DIRECTED BALLOON THERMODILUTION3Cleared 510(K)
- K812813INTERMEDICS PROGRAMMER, MODEL 522-033Cleared 510(K)
- K811217PACEMAKER PROGRAMMER #20103Cleared 510(K)
- K810552CORDIS PACEMAKER PROGRAMMERS 255A & 256A3Cleared 510(K)
- K800376EPR-200 PROGRAMMER MODEL 0103Cleared 510(K)
- K792580PACEMAKER PROGRAMMER3Cleared 510(K)
- K791419OMNICOR PROGRAMMER MODEL 222C3Cleared 510(K)
- K790220PACEMAKER PROGRAMMER3Cleared 510(K)
- K780175RATE PROGRAMMER MODEL 5203Cleared 510(K)
- K771855OMNICOR PROGRAMMER MODEL 222A3Cleared 510(K)
- 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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EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- St. Jude Medical, Inc.
- Trade Name
- MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S
- Generic Name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision Date
- 3/22/1984
- Days to Decision
- 247 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval