|
Device | DISCOVERY & MERIDIAN PULSE GENERATORS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940031 |
Supplement Number | S018 |
Date Received | 03/03/1999 |
Decision Date | 05/06/1999 |
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 the introduction of an alternative lid for the accelerometer (to metal from ceramic) and the use of a silver thermoplastic to bond the accelerometer to the hybrid instead of epoxy. |