SYNVISC (HYLAN G-F 20)
FDA premarket approval P940015/S002 · decided 1999-02-19
Approval details
- PMA number
- P940015
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNVISC (HYLAN G-F 20)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 1998-10-16
- Decision date
- 1999-02-19
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for a manufacturing site located at Biomatrix, Inc., 1125 Pleasantview Terrace, Radgefield, NJ.
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