FRONTIER/FRONTIER II FAMILY OF CRT-PS

FDA premarket approval P030035/S053 · decided 2009-07-15

Approval details

PMA number

P030035

Supplement

S053

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

FRONTIER/FRONTIER II FAMILY OF CRT-PS

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2009-01-22

Decision date

2009-07-15

Days to decision

174 days

Decision code

APPR

Product code

NKE

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE ACCENT / ACCENT RF IMPLANTABLE PULSE GENERATORS AND ANTHEM / ANTHEM RF CRT-PS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCENT / ACCENT RF IMPLANTABLE PULSE GENERATORS AND ANTHEM / ANTHEM RF CRT-PS. THE DEVICE IS INDICATED FOR: 1) MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONEAN 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

510(k) clearances by this applicant