|
Device | CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S047 |
Date Received | 05/26/2005 |
Decision Date | 06/14/2005 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement USE OF AN ALTERNATE EPOXY IN THE MANUFACTURE OF POWER MODULES FOR THE VITALITY FAMILY OF ICDS AND THE CONTAK RENEWAL FAMILY OF CRT-D DEVICES. |