PMA P880086S109

Device
AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S109
Product code
KRG
Decision date
2005-10-14
Classification
Programmer, Pacemaker
Generic name
Programmer, pacemaker
Approval order statement
ALTERNATE VENDOR OF QUADPOLAR FEEDTHROUGH ASSEMBLY FOR USE WITH AFFINITY, IDENTITY, INTEGRITY AND ENTITY FAMILY OF ICDS.

Current openFDA PMA Record#

Device
AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S109
Product code
KRG
Generic name
Programmer, pacemaker
Decision date
2005-10-14
Decision code
OK30
Date received
2005-09-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE VENDOR OF QUADPOLAR FEEDTHROUGH ASSEMBLY FOR USE WITH AFFINITY, IDENTITY, INTEGRITY AND ENTITY FAMILY OF ICDS.