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 MINI 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 | S008 |
Date Received | 06/13/1995 |
Decision Date | 12/21/1995 |
Product Code |
LWS |
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 MINI AICD SYSTEM, WHICH INCLUDES:MODEL NUMBERS 1645, 1740, 1741, 1745, AND 1746 PULSE GENERATORS; MODEL 2840 SOFTWARE APPLICATION; MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU); AND MODEL 6996 DF-1 PLUG |
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