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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 NameVENTAK AV AICD FAMILY SYSTEMS
Generic Nameimplantable cardioverter defibrillator
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP960040
Supplement NumberS007
Date Received11/25/1998
Decision Date12/08/1998
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the physician's manuals of the ventak(r) av(tm) aicd(tm) systems.
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