This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Change in supplier and temperature for one of the manufacturing steps.
| Device | Transcend Hip Articulation 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 | CERAMTEC GMBH |
| Date Received | 2018-03-19 |
| Decision Date | 2018-04-20 |
| PMA | P010001 |
| Supplement | S018 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CERAMTEC GMBH ceramtec-platz 1-9 73207 plochingen 73207 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010001 | Original Filing | |
| S025 | 2022-06-21 | 30-day Notice |
| S024 | 2021-08-05 | 30-day Notice |
| S023 | 2021-06-07 | 30-day Notice |
| S022 | 2019-12-23 | 30-day Notice |
| S021 | ||
| S020 | 2019-07-11 | 30-day Notice |
| S019 | 2019-01-28 | 30-day Notice |
| S018 | 2018-03-19 | 30-day Notice |
| S017 | 2016-01-28 | 30-day Notice |
| S016 | 2016-01-27 | 30-day Notice |
| S015 | 2016-01-27 | 30-day Notice |
| S014 | 2015-10-30 | 30-day Notice |
| S013 | 2015-05-29 | 30-day Notice |
| S012 | 2015-05-15 | 30-day Notice |
| S011 | 2015-02-06 | 30-day Notice |
| S010 | 2011-06-10 | 135 Review Track For 30-day Notice |
| S009 | 2011-03-17 | 135 Review Track For 30-day Notice |
| S008 | 2011-02-04 | 30-day Notice |
| S007 | 2010-04-21 | 135 Review Track For 30-day Notice |
| S006 | 2010-04-21 | 135 Review Track For 30-day Notice |
| S005 | 2010-03-22 | 135 Review Track For 30-day Notice |
| S004 | 2007-07-18 | 30-day Notice |
| S003 | 2006-03-22 | Normal 180 Day Track No User Fee |
| S002 | 2005-07-25 | 135 Review Track For 30-day Notice |
| S001 | 2003-02-20 | Normal 180 Day Track |