|
Device | DISCOVERY/MERIDIAN 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 | S021 |
Date Received | 10/04/1999 |
Decision Date | 10/20/1999 |
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 Software Application Model 2890 Revision 3.27 which removes automatic Minute Ventilation (MV) initialization, adds a "pop-up" warning ont he programmer screen prior to manual MV initialization, and corrects several minor anomalies applicable to the entire PDM pacemaker line. |