|
Device | EPIC HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S198 |
Date Received | 08/08/2011 |
Decision Date | 09/08/2011 |
Product Codes |
LWP LWS NIK NKE |
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 MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS. |