PMA P880086S079

Device: AFFINITY FAMILY OF PULSE GENERATORS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S079
Product code: DXY
Decision date: 2000-11-21
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
Approval order statement: APPROVAL FOR THE ADDITION OF A LAYER OF KAPTON TAPE (A POLYIMIDE FILM) TO THE EDGE SIDE OF THE DEVICES' BATTERY CASE OF THE AFFINITY FAMILY OF PULSE GENERATORS.

Current openFDA PMA Record#

Device: AFFINITY FAMILY OF PULSE GENERATORS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S079
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2000-11-21
Decision code: APPR
Date received: 2000-10-16
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF A LAYER OF KAPTON TAPE (A POLYIMIDE FILM) TO THE EDGE SIDE OF THE DEVICES' BATTERY CASE OF THE AFFINITY FAMILY OF PULSE GENERATORS.