|
Device | EPIC/ATLAS/PROMOTE 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 | S163 |
Date Received | 07/19/2010 |
Decision Date | 08/13/2010 |
Product Code |
NIK |
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 REDUCTION IN RECEIVING INSPECTION SAMPLE SIZES FOR COMPONENTS USED IN THE MANUFACTURING OF CAPACITORS. |
Post-Approval Study | Show Report Schedule and Study Progress |