|
Device | DISCOVERY/MERIDIAN/PULSAR PACEMAKERS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940031 |
Supplement Number | S024 |
Date Received | 05/09/2000 |
Decision Date | 06/20/2000 |
Product Codes |
KRG LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MARKET BOTH COATED AND UNCOATED VERSIONS OF THE ABOVE PACEMAKERS. |