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.
Addition to the depuy (ireland) ltd. Facility of an optimal in-process cleanline and three new pieces of equipment: a mazak integrex machining centre, a schlick blast unit and a trumpf laser-marking machine.
| Device | CHARITE ARTIFICIAL DISC |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | DEPUY SPINE,INC |
| Date Received | 2006-11-16 |
| Decision Date | 2006-12-15 |
| PMA | P040006 |
| Supplement | S003 |
| Product Code | MJO |
| 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 SPINE,INC 325 Paramont Drive raynham, MA 02767 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040006 | Original Filing | |
| S005 | 2011-01-11 | Special (immediate Track) |
| S004 | 2007-03-08 | Normal 180 Day Track |
| S003 | 2006-11-16 | 30-day Notice |
| S002 | 2005-02-22 | Normal 180 Day Track |
| S001 | 2005-01-07 | Normal 180 Day Track No User Fee |