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 for a change in the material of the inner pouch which holds the sterile porous hip cups, including components of the device.
| Device | C2A-TAPER ACETABULAR SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | Biomet, Inc. |
| Date Received | 2007-09-27 |
| Decision Date | 2009-04-17 |
| PMA | P050009 |
| Supplement | S004 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Biomet, Inc. p.o. Box 587 warsaw, IN 46581-0587 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050009 | Original Filing | |
| S009 | 2010-02-16 | Normal 180 Day Track No User Fee |
| S008 | ||
| S007 | 2009-02-19 | 30-day Notice |
| S006 | ||
| S005 | 2007-11-02 | 30-day Notice |
| S004 | 2007-09-27 | 135 Review Track For 30-day Notice |
| S003 | ||
| S002 | 2006-05-19 | 30-day Notice |
| S001 | 2006-01-10 | 30-day Notice |