|
Device | DELTA PACEMAKER SYSTRM; VIGOR DDD MODEL 950 (MASTER) |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P840068 |
Supplement Number | S027 |
Date Received | 08/09/1995 |
Decision Date | 03/12/1996 |
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 APRPOVAL FOR ADDING AN ALTERNATE LOWER PROFILE CONNECTOR TOP FOR THE VIGOR DDD MODEL 950 PACEMAKER |