|
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 | S286 |
Date Received | 05/19/2015 |
Decision Date | 07/13/2015 |
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 MERLIN@HOME EX1150W/EX1100W-MX (MODEM EXTRACTED) TO BE USED WITH THE DEVICES. |