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 a manufacturing sites located at depuy (ireland) ltd, cork, ireland, for manufacturing and isotron plc, marcus close, berkshire, united kingdom, for sterilization.
| Device | CHARITE ARTIFICIAL DISC |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | DEPUY SPINE,INC |
| Date Received | 2005-01-07 |
| Decision Date | 2005-06-16 |
| PMA | P040006 |
| Supplement | S001 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Express Gmp Supplement |
| 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 |