Approval for labeling updates incorporating results of the completed post-approval study.
| Device | TRIDENT CERAMIC-ON-CERAMIC ACETABULAR SYSTEM |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. |
| Date Received | 2011-11-10 |
| Decision Date | 2012-11-02 |
| PMA | P000013 |
| Supplement | S011 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive mahwah, NJ 07430 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000013 | | Original Filing |
| S020 |
2022-03-03 |
Special (immediate Track) |
| S019 |
2022-02-03 |
30-day Notice |
| S018 |
2021-01-05 |
Real-time Process |
| S017 |
2020-07-06 |
Real-time Process |
| S016 |
2018-11-26 |
30-day Notice |
| S015 |
2018-09-20 |
30-day Notice |
| S014 | | |
| S013 |
2016-02-04 |
30-day Notice |
| S012 |
2015-10-01 |
30-day Notice |
| S011 |
2011-11-10 |
Normal 180 Day Track No User Fee |
| S010 |
2011-10-03 |
Real-time Process |
| S009 |
2009-04-16 |
Special (immediate Track) |
| S008 |
2006-12-29 |
Real-time Process |
| S007 | | |
| S006 |
2006-02-22 |
30-day Notice |
| S005 |
2004-09-09 |
Real-time Process |
| S004 |
2004-04-15 |
Real-time Process |
| S003 |
2003-08-13 |
Normal 180 Day Track No User Fee |
| S002 |
2003-06-12 |
Real-time Process |
| S001 |
2003-02-04 |
Real-time Process |
NIH GUDID Devices