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 pcm cervical disc system. This device is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from c3-c4 to c6-c7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging(ct, mri, x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The pcm cervical disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the pcm cervical disc.
| Device | NUVASIVE PCM CERVICAL DISC SYSTEM |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | NUVASIVE, INC. |
| Date Received | 2010-04-01 |
| Decision Date | 2012-10-26 |
| Notice Date | 2012-11-08 |
| PMA | P100012 |
| Supplement | S |
| Product Code | MJO |
| Docket Number | 12M-1111 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NUVASIVE, INC. 7475 Lusk Blvd san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |