|
Device | EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES 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 | S181 |
Date Received | 03/14/2011 |
Decision Date | 06/21/2011 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR SOFTWARE MODEL MN5000 V.5.0 FOR USE ON THE MERLIN.NET SYSTEM AND MODEL EX2000 V.5.0 FOR USE ON MERLIN@ HOME DEVICES. |
Approval Order | Approval Order |