|
Device | EPIC HF/ATLAS HF FAMILY OF 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 | S081 |
Date Received | 02/06/2008 |
Decision Date | 03/06/2008 |
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 MINOR MODIFICATIONS TO THE CONTROLLER INTEGRATED CIRCUIT CHIPS USED IN THE CURRENT ICD AND PROMOTE CRT-D DEVICES. |