FRONTIER/FRONTIER II FAMILY OF CRT-PS

FDA premarket approval P030035/S028 · decided 2007-05-07

Approval details

PMA number

P030035

Supplement

S028

Supplement type

Real-Time Process

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

2007-04-06

Decision date

2007-05-07

Days to decision

31 days

Decision code

APPR

Product code

NKE

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING: ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS. THE DEVICES

510(k) clearances by this applicant