|
Device | UNIFY AND UNIFY QUANDRA 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 | S248 |
Date Received | 05/13/2013 |
Decision Date | 06/12/2013 |
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 |
Approval Order Statement ST. JUDE MEDICAL CRMDSYLMAR CA 91342 MODIFICATION OF THE HYBRID POST BURN-IN ATE TESTING FOR THE DEVICES. |