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 to suspend the post approval study based on suspension of marketing and sales in the us.
| Device | C2A-TAPER ACETABULAR HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | Biomet, Inc. |
| Date Received | 2010-02-16 |
| Decision Date | 2011-02-11 |
| PMA | P050009 |
| Supplement | S009 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| 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 |