PMA supplement
P050050 S020: Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)
FDA PMA supplement · Special (Immediate Track) · Djo Global
Key facts
| Original PMA | P050050 |
|---|---|
| Supplement number | S020 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Scandinavian Total Ankle Replacement (S.T.A.R. Ankle) |
| Generic name | Prosthesis, ankle, uncemented, non-constrained |
| Applicant | Djo Global |
| Product code | NTG |
| Received date | Nov 19, 2021 |
| Decision date | Dec 17, 2021 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: