|
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 | S016 |
Date Received | 08/24/1998 |
Decision Date | 10/02/1998 |
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 changes to the Model 2890 Software Application from Version 1.20 to Version 2.12 which consist primarily of usability changes (screen changes, usability features), corrections of anomalies, and the addition of a high rate single chamber temporary pacing mode (up to 380 ppm) to the DISCOVERY(TM)/MERIDIAN(TM) pacemakers which provides consistency with the VIGOR pacemakers. |