SYNVISC and SYNVISC ONE
FDA premarket approval P940015/S047 · decided 2021-10-27
Approval details
- PMA number
- P940015
- Supplement
- S047
- 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
- 2021-04-30
- Decision date
- 2021-10-27
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for the use of existing filling and parts washing machines to manufacture a biologic when not in use for the manufacture of Synvisc and Synvisc-One.
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