SYNVISC (HYLAN G-F 20)
FDA premarket approval P940015/S009 · decided 2003-03-14
Approval details
- PMA number
- P940015
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- 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
- 2003-02-14
- Decision date
- 2003-03-14
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR THE ADDITION OF THE FOLLOWING PRECAUTION STATEMENT TO THE SYNVISC PHYSICIAN PACKAGE INSERT: "TWIST THE GRAY TIP CAP BEFORE PULLING IT OFF, AS THIS WILL MINIMIZE PRODUCT LEAKAGE".
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