- Device
- Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S019
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2021-08-23
- Decision code
- APPR
- Date received
- 2021-07-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for revisions to device labeling that was updated to include information on the Post-Approval Study(PAS)of the Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)..