PMA P880086S101

Device: IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S101
Product code: DXY
Decision date: 2004-11-22
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
Approval order 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.

Current openFDA PMA Record#

Device: IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S101
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2004-11-22
Decision code: APPR
Date received: 2004-08-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.