IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS

FDA premarket approval P880086/S101 · decided 2004-11-22

Approval details

PMA number

P880086

Supplement

S101

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS

Generic name

implantable pacemaker Pulse-generator

Applicant

ABBOTT MEDICAL

Date received

2004-08-30

Decision date

2004-11-22

Days to decision

84 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE FOLLOWING: 1) A FIRMWARE MODIFICATION TO THE IDENTITY/IDENTITY ADX FAMILY OF PACEMAKERS TO CORRECT A POTENTIAL CONDITION THAT WOULD RESULT IN HARDWARE BACK-UP VVI PACING; AND 2) A COMPONENT DESIGN CHANGE TO IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILY OF PACEMAKERS MODIFYING THE PRINTED CIRCUIT BOARD USED TO CONNECT THE FEEDTHROUGH TO THE PACEMAKER CIRCUITRY.

510(k) clearances by this applicant