|
Device | CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) INVIVE AND INTUA MODELS |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | GUIDANT CORP. 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P030005 |
Supplement Number | S105 |
Date Received | 01/30/2014 |
Decision Date | 02/27/2014 |
Product Code |
NKE |
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 ADD INSPECTION CRITERIA AT THE SPOT-WELDING STEP BEFORE SPOT-WELDING THE FEEDTHRU WIRES TO THE CONNECTOR BLOCKS. |