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 the change in tolerance of the implant dimensions and the subsequent independent inspection of these dimensions.
| Device | IN MOTION LUMBAR ARTIFICIAL DISC |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | DEPUY SPINE,INC |
| Date Received | 2011-01-11 |
| Decision Date | 2011-02-08 |
| PMA | P040006 |
| Supplement | S005 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| 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 |