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 changes to the warnings and precautions section of the package insert labeling to include additional statements that advise the surgeon to avoid the taper region and shell face of the metal acetabular shell component when impacting the shell to adjust the position of the component.
| Device | DURALOC OPTION CERAMIC HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. |
| Date Received | 2006-09-19 |
| Decision Date | 2006-10-18 |
| PMA | P040023 |
| Supplement | S008 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |