BRYAN Cervical Disc
FDA premarket approval P060023/S008 · decided 2020-03-18
Approval details
- PMA number
- P060023
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- BRYAN Cervical Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Companion Spine France Sas
- Date received
- 2019-10-18
- Decision date
- 2020-03-18
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac
- 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.
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