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.
Manufacturing process changes by ceramtec, inc. , for the biolox forte ceramic femoral heads and inserts
| Device | CERAMIC TRANSCEND 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 | 2006-01-30 |
| Decision Date | 2006-02-16 |
| PMA | P030027 |
| Supplement | S001 |
| 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 | 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 |