Synvisc and Synvisc-One
FDA premarket approval P940015/S041 · decided 2018-11-02
Approval details
- PMA number
- P940015
- Supplement
- S041
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Synvisc and Synvisc-One
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2018-05-24
- Decision date
- 2018-11-02
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for an additional test point for sterility and endotoxin during manufacturing of the SynVisc and SynVisc One devices.
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