BRYAN CERVICAL DISC SYSTEM
FDA premarket approval P060023/S005 · decided 2016-08-11
Approval details
- PMA number
- P060023
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRYAN CERVICAL DISC SYSTEM
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Companion Spine France Sas
- Date received
- 2016-07-11
- Decision date
- 2016-08-11
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac
- Statement
- Site change for a manufacturing supplier.
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