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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 TM SYSTEM
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS002
Date Received09/30/1997
Decision Date12/09/1997
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
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" rather than joules "delivered".
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