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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGEM III VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD)
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS015
Date Received11/01/2000
Decision Date12/12/2000
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for medtronic gem iii vr model 7231 icd and medtronic model 9971 (gem iii vr) programmer application software. The device, as modified, is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
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