|
Device | MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940031 |
Supplement Number | S017 |
Date Received | 07/30/1998 |
Decision Date | 08/21/1998 |
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 modifications to the DISCOVERY and MERIDIAN pacemakers consisting of changes to the firmware to enhance the performance of existing diagnostic features, and a hardware change to the mixed mode integrated circuit chip to increase the maximum selectable pacing amplitude. |