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 the addition of the zimmer manufacturing b. V. Facility located in ponce, puerto rico as an alternative site for manufacturing the versys heritage femoral stems.
| Device | TRILOGY AB ACETABULAR SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | ZIMMER, INC. |
| Date Received | 2007-01-26 |
| Decision Date | 2007-06-08 |
| PMA | P040048 |
| Supplement | S002 |
| 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 | ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040048 | Original Filing | |
| S017 | 2012-04-06 | 135 Review Track For 30-day Notice |
| S016 | 2012-01-12 | 30-day Notice |
| S015 | 2011-06-14 | Normal 180 Day Track No User Fee |
| S014 | 2011-05-02 | Special (immediate Track) |
| S013 | ||
| S012 | 2009-11-24 | 30-day Notice |
| S011 | 2009-11-23 | 30-day Notice |
| S010 | 2009-11-09 | 30-day Notice |
| S009 | 2009-09-14 | Normal 180 Day Track No User Fee |
| S008 | 2009-05-11 | Normal 180 Day Track No User Fee |
| S007 | ||
| S006 | ||
| S005 | 2008-04-17 | 30-day Notice |
| S004 | 2008-04-16 | 135 Review Track For 30-day Notice |
| S003 | 2007-11-30 | 135 Review Track For 30-day Notice |
| S002 | 2007-01-26 | 135 Review Track For 30-day Notice |
| S001 | 2006-10-12 | Normal 180 Day Track No User Fee |