|
Device | EPIC/EPIC II HF & ATLAS + HF CRT-D'S |
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 | S030 |
Date Received | 06/07/2006 |
Decision Date | 07/11/2006 |
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 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER. |