|
Device | EPIC HF & ATLAS + HF CRT-D SYSTEMS |
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 | S005 |
Date Received | 01/24/2005 |
Decision Date | 03/08/2005 |
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 MODEL 3307 V.4.8.3 AND MODEL 3307 V.4.8.4 PROGRAMMER SOFTWARE. |
Post-Approval Study | Show Report Schedule and Study Progress |