|
Device | IMPLANTABLE CARDIAC PACEMAKER PULSE GENERATOR |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P880006 |
Supplement Number | S076 |
Date Received | 11/30/2011 |
Decision Date | 04/13/2012 |
Withdrawal Date
|
05/07/2018 |
Product Code |
NIK |
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 | Yes |
Approval Order Statement APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS. |