|
Device | FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM |
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 | S002 |
Date Received | 08/13/2004 |
Decision Date | 01/14/2005 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY FOR YOUR DEVICE. |