Approval for changes to the surgical technique manual (i. E. , modification of figure 8 and the addition of a cautionary note).
| Device | PRESTIGE CERVICAL DISC |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. |
| Date Received | 2007-09-07 |
| Decision Date | 2007-09-18 |
| PMA | P060018 |
| Supplement | S001 |
| 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 | MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place memphis, TN 38132 |
Supplemental Filings
| 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) |
NIH GUDID Devices