|
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 | S035 |
Date Received | 05/07/1998 |
Decision Date | 05/28/1998 |
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 the VIGOR Model 2880 Software Application, Version 4.1, which corrects anomalies discovered during clinical use of the programmer software. |