BRYAN CERVICAL DISC
FDA premarket approval P060023/S001 · decided 2012-03-09
Approval details
- PMA number
- P060023
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRYAN CERVICAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Companion Spine France Sas
- Date received
- 2010-05-18
- Decision date
- 2012-03-09
- Days to decision
- 661 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac
- Statement
- APPROVAL FOR A MODIFIED SURGICAL TECHNIQUE, NEW INSTRUMENTATION, AND MODIFIED LABELING TO INCLUDE INFORMATION ON MRI COMPATIBILITY OF THE IMPLANTED DEVICE.
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