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 | VISTA 4, 6, & T; DELTA T & TRS; VISTA DD; AND VIGOR DDD |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P840068 |
Supplement Number | S026 |
Date Received | 06/26/1995 |
Decision Date | 04/16/1996 |
Product Code |
LWP |
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 REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE CARDIAC PACEMAKER MODELS, PELLETHANE 2363-75D POLYURETHANE WITH TECOTHANE TT1075D-M POLYURETHANE |
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