|
Device | EPIC HF & EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.1M SOFTWARE |
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 | S025 |
Date Received | 03/30/2006 |
Decision Date | 04/28/2006 |
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 3307 V.6.1M PROGRAMMER SOFTWARE. |