Approval for labeling for the bryan® cervical disc which incorporate the final results of the 10-year post-approval study and enhanced surveillance findings.
| Device | BRYAN Cervical Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Date Received | 2019-10-18 |
| Decision Date | 2020-03-18 |
| PMA | P060023 |
| Supplement | S008 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P060023 | | Original Filing |
| S008 |
2019-10-18 |
Normal 180 Day Track No User Fee |
| S007 | | |
| S006 |
2017-07-13 |
Normal 180 Day Track No User Fee |
| S005 |
2016-07-11 |
30-day Notice |
| S004 |
2012-12-13 |
30-day Notice |
| S003 |
2012-05-04 |
135 Review Track For 30-day Notice |
| S002 |
2011-04-15 |
135 Review Track For 30-day Notice |
| S001 |
2010-05-18 |
Normal 180 Day Track |
NIH GUDID Devices