|
Device | EPIC HF/ATLAS+HF/PROMOTE 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 | S199 |
Date Received | 08/31/2011 |
Decision Date | 09/28/2011 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MODEL 3300 VERSION 12.1.10 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM. |
Post-Approval Study | Show Report Schedule and Study Progress |