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 III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATION |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S006 |
Date Received | 04/22/1998 |
Decision Date | 08/31/1998 |
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 III DR AICD(TM) System with Model 2843 Software, Version 2.6, the use of Version 2.6 with the VENTAK(R) AV II DR System and modifications to the Physician's Manual and the DR System and modifications tot he Physicians's Manual and the Patient's Manual. |
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