AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

FDA premarket approval P880086/S142 · decided 2007-05-07

Approval details

PMA number

P880086

Supplement

S142

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2007-04-06

Decision date

2007-05-07

Days to decision

31 days

Decision code

APPR

Product code

NVZ

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