PMA P880086S320
- Device
- Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S320
- Product code
- DXY
- Decision date
- 2021-07-07
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Adjust Bioburden action limit and alert levels at the Sylmar manufacturing site.
Current openFDA PMA Record#
- Device
- Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S320
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2021-07-07
- Decision code
- OK30
- Date received
- 2021-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust Bioburden action limit and alert levels at the Sylmar manufacturing site.