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 | DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P840068 |
Supplement Number | S037 |
Date Received | 08/05/1998 |
Decision Date | 08/26/1998 |
Product Code |
LWP |
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 minor changes to the pacemaker top (header) and minor labeling changes for the Vigor SSI, Model 460 and Vigor SR, Model 1130. |
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