|
Device | SJM QUADRA ASSURA AND UNIFY ASSURA CRTDS |
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 | S227 |
Date Received | 07/19/2012 |
Decision Date | 09/06/2012 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERATIONS MALAYSIA (SJM-MYPE) IN PENANG, MALAYSIA. |