- Device
- Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S295
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2018-02-22
- Decision code
- OK30
- Date received
- 2018-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust the relative humidity in the device and leads manufacturing and product packaging areas located in the Sylmar, California facility.