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(R) MINI HC(HOT CAN) AICD SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S012 |
Date Received | 09/12/1995 |
Decision Date | 04/29/1996 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE VENTAK MINI HC (MODELS 1742, 1743, AND 1640) WHICH IS AN ACTIVE CAN VERSION OF YOUR COMMERCIALLY AVAILABLE VENTAK MINI AICD SYSTEM AND THE VENTAK MINI II HC AICD SYSTEM (MODELS 1652, 1662, 1752, 1762, 1753, AND 1763) WHICH IS A DOWN-SIZED VERSION OF THE VENTAK MINI HC AICD SYSTEM. THE MINI II HC MAXIMUM ENERGY LEVELS ARE 25 AND 27 JEWELS WHERE THE MINI HC MAXIMUM ENERGY LEVEL IS 29 JEWELS |
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