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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 P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantGUIDANT CORP.
PMA NumberP930035
Supplement NumberS008
Date Received09/30/1997
Decision Date12/15/1997
Product Code
LWS[ Registered Establishments with LWS ]
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 the ventak(r) av ii pulse generator models 1820 and 1825, model 2833 application software, version 2,8 and revised labeling to include shock energy as joules "stored" rahter than joules "delivered".
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