SYNVISC & SYNVISC-ONE
FDA premarket approval P940015/S020 · decided 2011-03-18
Approval details
- PMA number
- P940015
- Supplement
- S020
- 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
- 2011-02-16
- Decision date
- 2011-03-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- FILLING OF AN INVESTIGATIONAL DRUG ON THE INOVA FILLER MACHINE, WHICH IS ALSO USED FOR FILLING THE SYNVISC AND SYNVISC-ONE PRODUCTS.
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