- Device
- Assurity, Assurity+, Endurity, Accent, Identity ADx XL, Sustain XL, Verity ADx XL, Victory XL, and Zephyr XL
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S294
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2018-02-01
- Decision code
- OK30
- Date received
- 2018-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of supplier manufacturing of certain battery components and use of an alternate component welding machine.