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 prestige cervical disc system. This device is indicated for reconstruction of the disc from c3-c7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The prestige device is implanted via an open anterior approach. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e. G. , pain [neck and/or arm pain], functional deficit, and/or neurological deficit), and radiographic studies (e. G. , ct, mri, x-rays, etc. ): 1) herniated disc, and/or 2) osteophyte formation.
| Device | PRESTIGE CERVICAL DISC SYSTEM |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. |
| Date Received | 2006-05-19 |
| Decision Date | 2007-07-16 |
| Notice Date | 2007-07-20 |
| PMA | P060018 |
| Supplement | S |
| Product Code | MJO |
| Docket Number | 07M-0289 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place memphis, TN 38132 |
| 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 |
|---|---|---|
| P060018 | Original Filing | |
| S005 | 2016-07-11 | 30-day Notice |
| S004 | 2016-01-29 | Normal 180 Day Track No User Fee |
| S003 | 2013-06-14 | 30-day Notice |
| S002 | 2010-10-26 | 135 Review Track For 30-day Notice |
| S001 | 2007-09-07 | Special (immediate Track) |
| Device ID | PMA | Supp |
|---|---|---|
| 00721902440236 | P060018 | 000 |
| 00721902440243 | P060018 | 000 |
| 00721902440250 | P060018 | 000 |
| 00721902451959 | P060018 | 000 |
| 00721902723223 | P060018 | 000 |
| 00721902723254 | P060018 | 000 |
| 00613994129215 | P060018 | 000 |
| 00613994129222 | P060018 | 000 |
| 00613994129239 | P060018 | 000 |
| 00613994129253 | P060018 | 000 |
| 00613994236982 | P060018 | 001 |
| 00613994237002 | P060018 | 001 |
| 00613994237019 | P060018 | 001 |
| 00613994237033 | P060018 | 001 |
| 00613994237040 | P060018 | 001 |
| 00613994237064 | P060018 | 001 |