PMA P880086S110

Device
IDENTITY/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S110
Product code
NVZ
Decision date
2006-01-31
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
APPROVAL FOR AN ALTERNATE ORGANIC FEEDTHRU SUBSTRATE TO BE USED IN THE AFFINITY, ENTITY, IDENTITY, IDENTITY ADX, INTEGRITY AND VERITY FAMILIES OF PULSE GENERATORS.

Current openFDA PMA Record#

Device
IDENTITY/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S110
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2006-01-31
Decision code
APPR
Date received
2005-10-07
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR AN ALTERNATE ORGANIC FEEDTHRU SUBSTRATE TO BE USED IN THE AFFINITY, ENTITY, IDENTITY, IDENTITY ADX, INTEGRITY AND VERITY FAMILIES OF PULSE GENERATORS.