ANTHEM AND FRONTIER II CRT-P'S

FDA premarket approval P030035 · decided 2004-05-13

Approval details

PMA number

P030035

Trade name

ANTHEM AND FRONTIER II CRT-P'S

Generic name

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Applicant

ABBOTT MEDICAL

Date received

2003-08-29

Decision date

2004-05-13

Days to decision

258 days

Decision code

APPR

Product code

NKE

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE ST. JUDE FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM. THE FRONTIER BIVENTRICULAR PACING SYSTEM IS INDICATED FOR 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.

510(k) clearances by this applicant