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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 II MODEL 7273/GEM DR 7271/GEM II VR 7229 ICDS
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS008
Date Received07/26/1999
Decision Date12/11/2000
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes of the medtronic models 7221, 7223, 7227, 7229, 7271 and 7273.
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