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.
Changes to the device sterile packaging.
| Device | DUROLOC OPTION CERAMIC HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. |
| Date Received | 2012-05-18 |
| Decision Date | 2012-06-15 |
| PMA | P040023 |
| Supplement | S022 |
| 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 | DEPUY ORTHOPAEDICS, INC. 700 Orthopaedic Drive warsaw, IN 46581-0988 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040023 | Original Filing | |
| S025 | 2012-10-25 | 30-day Notice |
| S024 | 2012-08-03 | Special (immediate Track) |
| S023 | ||
| S022 | 2012-05-18 | 30-day Notice |
| S021 | 2012-04-18 | Normal 180 Day Track No User Fee |
| S020 | 2012-03-27 | 30-day Notice |
| S019 | 2011-11-09 | Special (immediate Track) |
| S018 | 2011-09-16 | Real-time Process |
| S017 | ||
| S016 | 2009-12-11 | 135 Review Track For 30-day Notice |
| S015 | 2009-12-02 | 135 Review Track For 30-day Notice |
| S014 | 2009-10-19 | Normal 180 Day Track No User Fee |
| S013 | 2008-11-26 | 30-day Notice |
| S012 | 2008-11-18 | Normal 180 Day Track No User Fee |
| S011 | 2008-08-19 | 135 Review Track For 30-day Notice |
| S010 | 2007-10-12 | 30-day Notice |
| S009 | 2007-07-02 | Normal 180 Day Track No User Fee |
| S008 | 2006-09-19 | Special (immediate Track) |
| S007 | 2006-05-04 | Special (immediate Track) |
| S006 | 2006-05-02 | 135 Review Track For 30-day Notice |
| S005 | ||
| S004 | 2006-02-23 | Normal 180 Day Track No User Fee |
| S003 | 2005-11-21 | Special (immediate Track) |
| S002 | 2005-11-10 | Special (immediate Track) |
| S001 | 2005-09-02 | 135 Review Track For 30-day Notice |