BRYAN CERVICAL DISC
FDA premarket approval P060023/S004 · decided 2013-01-11
Approval details
- PMA number
- P060023
- Supplement
- S004
- Supplement type
- 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
- 2012-12-13
- Decision date
- 2013-01-11
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac
- Statement
- USE OF A NEW LOCATION FOR THE POROUS COATING PROCESS PERFORMED AT THE FIRM¿S SUPPLIER.
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