PMA P880086S125

Device
AFFINITY, INTEGRITY, AND IDENTITY PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S125
Product code
NVZ
Decision date
2006-08-16
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
SOFTWARE CHANGES TO THE DOWNLOADER AND TEST SYSTEM SOFTWARE FOR THE ABOVE LISTED DEVICES.

Current openFDA PMA Record#

Device
AFFINITY, INTEGRITY, AND IDENTITY PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S125
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2006-08-16
Decision code
OK30
Date received
2006-07-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
SOFTWARE CHANGES TO THE DOWNLOADER AND TEST SYSTEM SOFTWARE FOR THE ABOVE LISTED DEVICES.