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 VR OMDEL 1774/MODEL 1775 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH MODEL 2841 SOFTWARE APPLICATION |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S009 |
Date Received | 01/12/1999 |
Decision Date | 05/03/1999 |
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) VR AICD(TM) System with Model 2841 Software, Version 1.4. |
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