|
Device | DISCOVERY(TM)/MERIDIAN(TM) |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940031 |
Supplement Number | S025 |
Date Received | 01/19/2001 |
Decision Date | 02/26/2001 |
Product Codes |
KRG 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 INTRODUCTION OF THE PDM SOFTWARE APPLICATION MODEL 28990 VERSION 4.3. |