- Device
- Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S312
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2020-02-28
- Decision code
- OK30
- Date received
- 2020-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adopt sterilization recipe Cycle PG 600 for the Abbott Penang Malaysia manufacturing facility.