PMA P880086S168

Device: AFFINITY/INTEGRITY/VICTORY FAMILIES OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S168
Product code: NVZ
Decision date: 2008-10-01
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: ADDITION OF AN END OF LIFE (EL) COMMUNICATION SOFTWARE TEST TO THE AUTOMATED MANUFACTURING SOFTWARE TEST SUITE USED DURING HYBRID MANUFACTURING.

Current openFDA PMA Record#

Device: AFFINITY/INTEGRITY/VICTORY FAMILIES OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S168
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2008-10-01
Decision code: OK30
Date received: 2008-09-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF AN END OF LIFE (EL) COMMUNICATION SOFTWARE TEST TO THE AUTOMATED MANUFACTURING SOFTWARE TEST SUITE USED DURING HYBRID MANUFACTURING.