- Device
- VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S259
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2015-09-03
- Decision code
- OK30
- Date received
- 2015-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.