- Device
- Scandinavian Total Ankle Replacement (STAR Ankle)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S015
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2020-12-01
- Decision code
- OK30
- Date received
- 2020-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the gamma sterilization load configuration, positioning in the sterilization chamber and subsequent dose map validation.