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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 DR MODEL 7273
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS005
Date Received03/31/1999
Decision Date04/15/1999
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for screening the medtronic(r) model 7271 gem(tm) ii dual chamber implantable cardioverter defibrillators for premature battery depletion.
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