BRYAN CERVICAL DISC
FDA premarket approval P060023/S002 · decided 2012-09-13
Approval details
- PMA number
- P060023
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRYAN CERVICAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Companion Spine France Sas
- Date received
- 2011-04-15
- Decision date
- 2012-09-13
- Days to decision
- 517 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac
- Statement
- APPROVAL FOR A CHANGE TO THE INJECTION MOLDING PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.