SYNVISC-ONE (HYLAN G-F 20)
FDA premarket approval P940015/S017 · decided 2010-03-12
Approval details
- PMA number
- P940015
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNVISC-ONE (HYLAN G-F 20)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2010-01-29
- Decision date
- 2010-03-12
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- CHANGE TO THE AUTOMATED FILLING PROCESS FOR THE SYNVISC-ONE SYRINGES FROM USING THE COZZOLI FILLER TO USING THE INOVA VACUUM FILLER.
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