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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 NameMEDTRONIC GEMIII DR MODEL 7275 (ICD), MODEL 9970 PROGRAMMER APPLICATION SOFTWARE
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS014
Date Received09/11/2000
Decision Date11/29/2000
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for medtronic gem iii dr model 7275 icd and medtronic model 9970 (gem iii dr) 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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