|
Device | FRONTIER/FRONTIER 2 FAMILY OF CRT-PS |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030035 |
Supplement Number | S070 |
Date Received | 06/07/2010 |
Decision Date | 03/04/2011 |
Product Code |
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 THE MODEL 3330 VERSION 11.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |