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.
| Device | Transcend® Hip Articulation System |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | CERAMTEC GMBHceramtec-platz 1-973207plochingen 73207 PMA NumberP010001 Supplement NumberS025 Date Received06/21/2022 Decision Date07/20/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-21 |
| Decision Date | 2022-07-20 |
| PMA | P010001 |
| Supplement | S025 |
| 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 PMA NumberP010001 Supplement NumberS025 Date Received06/21/2022 Decision Date07/20/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement an Addition Of A Second Supplier For The Raw Material Alumina Used For The Production Of The Ceramic Material BIOLOX®forte |
| 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 |