Synvisc, Synvisc-One
FDA premarket approval P940015/S051 · decided 2023-01-13
Approval details
- PMA number
- P940015
- Supplement
- S051
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Synvisc, Synvisc-One
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2022-12-16
- Decision date
- 2023-01-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Replacement of the water distribution system (piping) used to supply water in the manufacture of Synvisc and Synvisc-One.
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