|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 Name||VENTAK AV AICD TM SYSTEM|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| 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".