FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS

FDA premarket approval P030035/S003 · decided 2005-04-29

Approval details

PMA number

P030035

Supplement

S003

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

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

Date received

2004-09-30

Decision date

2005-04-29

Days to decision

211 days

Decision code

APPR

Product code

NKE

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

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 F

510(k) clearances by this applicant