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 1) new endplates coated with vacuum plasma-sprayed pure titanium and calcium phosphate; 2) three new intermediate endplate sizes utilizing this same coating; and 3) various surgical instruments to accommodate the proposed new endplates.
| Device | CHARITE ARTIFICIAL DISC |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | DEPUY SPINE,INC |
| Date Received | 2005-02-22 |
| Decision Date | 2006-03-29 |
| PMA | P040006 |
| Supplement | S002 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |