PMA supplement
P050050 S019: Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)
FDA PMA supplement · Normal 180 Day Track No User Fee · Djo Global
Key facts
| Original PMA | P050050 |
|---|---|
| Supplement number | S019 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| 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 | Jul 9, 2021 |
| Decision date | Aug 23, 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: