BRYAN CERVICAL DISC
FDA premarket approval P060023/S003 · decided 2012-11-30
Approval details
- PMA number
- P060023
- Supplement
- S003
- 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
- 2012-05-04
- Decision date
- 2012-11-30
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac
- Statement
- APPROVAL FOR A REVISION TO THE BIOBURDEN ENUMERATION TEST FREQUENCY FOR ETHYLENE OXIDE.
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