SYNVISC & SYNVISC-ONE
FDA premarket approval P940015/S019 · decided 2010-09-15
Approval details
- PMA number
- P940015
- Supplement
- S019
- Supplement type
- 135 Review Track For 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
- 2010-06-09
- Decision date
- 2010-09-15
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- P940015/S0199/15/10135-DAY SYNVISC/SYNVISC-ONE AND PREVELLE SILK GENZYME BIOSURGERYCAMBRIDGE, MA02142 APPROVAL FOR A MANUFACTURING CHANGE INVOLVING INSTALLATION OF THE WATERS EMPOWER 2 CHROMATOGRAPHY DATA SYSTEM.
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