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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.
 
DeviceMEDTRONIC GEM II VR MODEL 7229 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
ms mvs11
mounds view, MN 55112
PMA NumberP980016
Supplement NumberS003
Date Received02/05/1999
Decision Date07/27/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 7229 (gem(tm) ii vr) implantable cardioverter defibrillator and model 9964 application software and the quality assurance test method and specification for screening the gem(tm) ii vr for premature battery depletion, and the revised l222 integrated circuit.
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