|
Device | EPIC HF/ATLAS + HF 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 | S189 |
Date Received | 05/02/2011 |
Decision Date | 08/03/2011 |
Product Codes |
LWP LWS NIK NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |