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.
Replacement of the previous software system with an image analyzer software and the revision of the porous coating test procedures.
| Device | C2A-TAPER ACETABULAR SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | Biomet, Inc. |
| Date Received | 2006-05-19 |
| Decision Date | 2006-06-16 |
| PMA | P050009 |
| Supplement | S002 |
| 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 | 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 |