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.
Approval of product labeling which was updated after the completion of post-approval study protocol.
| Device | Ceramic 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 | MicroPort Orthopedics Inc. |
| Date Received | 2012-02-08 |
| Decision Date | 2018-02-16 |
| PMA | P030027 |
| Supplement | S005 |
| Product Code | MRA |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 | MicroPort Orthopedics Inc. 5677 Airline Rd arlington, TN 38002-0000 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030027 | Original Filing | |
| S009 | 2016-03-11 | Normal 180 Day Track No User Fee |
| S008 | 2015-12-10 | 30-day Notice |
| S007 | 2013-04-26 | 135 Review Track For 30-day Notice |
| S006 | 2013-01-22 | 135 Review Track For 30-day Notice |
| S005 | 2012-02-08 | Normal 180 Day Track No User Fee |
| S004 | 2007-12-28 | 135 Review Track For 30-day Notice |
| S003 | ||
| S002 | 2006-03-08 | Real-time Process |
| S001 | 2006-01-30 | 30-day Notice |