Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VENTAK AV AICD TM SYSTEM |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S002 |
Date Received | 09/30/1997 |
Decision Date | 12/09/1997 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
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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