SYNVISC HYLAN G-F 20
FDA premarket approval P940015/S006 · decided 2003-09-26
Approval details
- PMA number
- P940015
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SYNVISC HYLAN G-F 20
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2002-03-19
- Decision date
- 2003-09-26
- Days to decision
- 556 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR LABELING CHANGES INCLUDING REMOVAL OF A PRECAUTION REGARDING REPEAT COURSES OF INJECTION, AND ADDING INFORMATION ABOUT ADVERSE EVENTS.
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