Approval for addition of a symbol to the package labels of star stainless steel instruments.
| Device | Scandinavian Total Ankle Replacement (S.T.A.R. Ankle) |
| Generic Name | Prosthesis, Ankle, Uncemented, Non-constrained |
| Applicant | DJO Global |
| Date Received | 2021-11-19 |
| Decision Date | 2021-12-17 |
| PMA | P050050 |
| Supplement | S020 |
| Product Code | NTG |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DJO Global 9800 Metric Boulevard austin, TX 78758 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050050 | | Original Filing |
| S025 |
2022-09-02 |
30-day Notice |
| S024 | | |
| S023 | | |
| S022 |
2022-02-01 |
30-day Notice |
| S021 | | |
| S020 |
2021-11-19 |
Special (immediate Track) |
| S019 |
2021-07-09 |
Normal 180 Day Track No User Fee |
| S018 |
2021-03-24 |
30-day Notice |
| S017 |
2021-02-16 |
30-day Notice |
| S016 |
2020-12-14 |
30-day Notice |
| S015 |
2020-11-02 |
30-day Notice |
| S014 |
2020-08-03 |
30-day Notice |
| S013 | | |
| S012 |
2018-08-21 |
Real-time Process |
| S011 |
2017-10-10 |
Real-time Process |
| S010 |
2016-07-12 |
Real-time Process |
| S009 | | |
| S008 |
2016-04-11 |
Normal 180 Day Track No User Fee |
| S007 |
2014-03-11 |
Normal 180 Day Track No User Fee |
| S006 |
2014-03-10 |
Real-time Process |
| S005 |
2012-11-13 |
Special (immediate Track) |
| S004 |
2012-09-04 |
Normal 180 Day Track No User Fee |
| S003 | | |
| S002 |
2009-08-21 |
Normal 180 Day Track No User Fee |
| S001 |
2009-08-05 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices