|
Device | CONTAK RENEWAL 3&4 FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES |
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 | S061 |
Date Received | 08/04/2005 |
Decision Date | 09/21/2005 |
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 |
Approval Order Statement ADDITION OF AN AUTOMATED VISION SYSTEM (EQUIPMENT) TO THE INSPECTION PROCESS FOR INSPECTION OF HEADERS THAT WILL REPLACE THE MANUAL VISUAL INSPECTION PROCESS TO THE FAMILY OF CRT AND ICD DEVICES. |