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.
Use of new labeling software.
| Device | TRILOGY AB ACETABULAR SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | ZIMMER, INC. |
| Date Received | 2012-01-12 |
| Decision Date | 2012-02-10 |
| PMA | P040048 |
| Supplement | S016 |
| 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 | 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 |