|
Device | PULSAR/DISCOVERY/MERIDIAN |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940031 |
Supplement Number | S051 |
Date Received | 03/03/2006 |
Decision Date | 03/31/2006 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A REQUIREMENT FOR THE THICKNESS OF THE GOLD PLATING ON THE ACCELEROMETER BOND PAD FOR THE DEVICES. |