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) PRX (TM) II 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 | S011 |
Date Received | 08/25/1995 |
Decision Date | 02/05/1996 |
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 USE OF MODEL 2872 SOFTWARE APPLICATION, REV. 4.1 AND MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) WITH THE VENTAK PRX II/III PULSE GENERATOR AND MODEL 2950 PRM |
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