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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 NameMODEL 7271 GEM DR ICD
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS007
Date Received07/07/1999
Decision Date08/12/1999
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the high power circuitry of the medtronic(r) model 7271 gem(r) dr implantable cardioverter defibrillator.
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