|
Device | QUADRA ASSURA/UNIFY ASSURA 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 | S265 |
Date Received | 04/15/2014 |
Decision Date | 05/29/2014 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 3330 VERSION 18.1.1 SOFTWARE FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER MODEL 3650. |