|
Device | EPIC HF/ATLAS+HF FAMILY OF CRT-DS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S156 |
Date Received | 06/24/2010 |
Decision Date | 07/21/2010 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE IMPROVEMENT OF THE MANUFACTURE AND QA PROCESS BY INSERTING THE INSPECTIONS TO THE BATTERY WELDING. |