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 labeling changes to the patient brochure.
| Device | PCM CERVICAL DISC |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | NUVASIVE, INC. |
| Date Received | 2013-01-22 |
| Decision Date | 2013-03-29 |
| PMA | P100012 |
| Supplement | S002 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NUVASIVE, INC. 7475 Lusk Blvd san Diego, CA 92121 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100012 | Original Filing | |
| S008 | 2018-05-03 | Normal 180 Day Track No User Fee |
| S007 | ||
| S006 | 2014-09-26 | Normal 180 Day Track |
| S005 | 2013-12-18 | Real-time Process |
| S004 | 2013-03-04 | Normal 180 Day Track No User Fee |
| S003 | 2012-11-19 | Normal 180 Day Track No User Fee |
| S002 | 2013-01-22 | Special (immediate Track) |
| S001 | 2012-11-19 | Normal 180 Day Track No User Fee |