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 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S027 |
Date Received | 02/17/1999 |
Decision Date | 03/17/1999 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a design and manufacturing change to the pulse generator hybrid assembly for the VENTAK(R) MINI III(TM) and MINI IV(TM) AICD(TM) Systems (Models 1782, 1783, 1786, 1788, 1789, 1790, 1792, 1793, and 1796). |
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