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.
Addition of ceramtech's marktredwitz facility for the use of the hot isostatic pressure (hip) process.
| 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 | 2015-12-10 |
| Decision Date | 2015-12-30 |
| PMA | P030027 |
| Supplement | S008 |
| 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 |