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 PRX AICD, VENTAK PRX II AICD, VENTAK PRX III AICD, VENTAK MINI AICD, VENTAK MINI HC AICD, VENTAK II AICD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S015 |
Date Received | 05/10/1996 |
Decision Date | 05/15/1996 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE VENTAK PRX AICD (MODELS 1700 AND 1705), VENTAK PRX II AICD MODEL 1715, VENTAK PRX III AICD (MODELS 1720 AND 1725), VENTAK MINI AICD (MODELS 1645, 1740, 1741, 1745, AND 1746), VENTAK MINI HC AICD (MODELS 1742, 1743 AND 1640), AND VENTAK MINI AICD (MODELS 1652, 1662, 1752, 1762, 1753, AND 1763) WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE |
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