SYNVISC ONE
FDA premarket approval P940015/S040 · decided 2017-05-11
Approval details
- PMA number
- P940015
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNVISC ONE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2017-04-17
- Decision date
- 2017-05-11
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Modifications to the sterilization process of a component used to manufacture Synvisc and Synvisc-One.
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