|
Device | PRIZM, PRIZM II CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S143 |
Date Received | 02/12/2007 |
Decision Date | 09/19/2007 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN ALTERNATE SUPPLIER FOR INTEGRATED CIRCUIT WAFER GOLD BUMPING SERVICE FOR THE PRIZM AND PRIZM II CRT-D DEVICES. |