PMA P060023S008
- Device
- BRYAN Cervical Disc
- Applicant
- Companion Spine France Sas
- PMA number
- P060023
- Supplement
- S008
- Product code
- MJO
- Decision date
- 2020-03-18
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for labeling for the BRYAN® Cervical Disc which incorporate the final results of the 10-year Post-Approval Study and Enhanced Surveillance findings.
Current openFDA PMA Record#
- Device
- BRYAN Cervical Disc
- Applicant
- Companion Spine France Sas
- PMA number
- P060023
- Supplement
- S008
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2020-03-18
- Decision code
- APPR
- Date received
- 2019-10-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling for the BRYAN® Cervical Disc which incorporate the final results of the 10-year Post-Approval Study and Enhanced Surveillance findings.