FRONTIER/FRONTIER II FAMILY OF CRT-P'S

FDA premarket approval P030035/S031 · decided 2007-05-09

Approval details

PMA number

P030035

Supplement

S031

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

FRONTIER/FRONTIER II FAMILY OF CRT-P'S

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2007-04-23

Decision date

2007-05-09

Days to decision

16 days

Decision code

APPR

Product code

NKE

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WI

510(k) clearances by this applicant