|
Device | FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS |
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 | S003 |
Date Received | 09/30/2004 |
Decision Date | 04/29/2005 |
Product Code |
NKE |
Docket Number | 05M-0289 |
Notice Date | 07/26/2005 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FRONTIER CARDIAC RESYNCHRONIZATION THERAPY SYSTEM. THESE DEVICES ARE INDICATED FOR: 1) MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE. 2) THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRS DURATION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|