PMA P880086S264

Device: VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S264
Product code: NVZ
Decision date: 2015-12-07
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: THE USE OF A MOLD RELEASE AGENT ON HEADER CASTING ASSEMBLIES IN THE ABOVE DEVICES.

Current openFDA PMA Record#

Device: VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S264
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2015-12-07
Decision code: OK30
Date received: 2015-11-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: THE USE OF A MOLD RELEASE AGENT ON HEADER CASTING ASSEMBLIES IN THE ABOVE DEVICES.