This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the charite artificial disc. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (ddd) at one level from l4-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients should have no more than 3 mm of spondylolisthesis at the involved level. Patients receiving the charite artificial disc should have failed at least six months of conservative treatment prior to implantation of the charite artificial disc.
| Device | CHARITE ARTIFICIAL DISC |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | DEPUY SPINE,INC |
| Date Received | 2004-02-13 |
| Decision Date | 2004-10-26 |
| Notice Date | 2005-03-09 |
| PMA | P040006 |
| Supplement | S |
| Product Code | MJO |
| Docket Number | 05M-0092 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | DEPUY SPINE,INC 325 Paramont Drive raynham, MA 02767 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |