SYNVISC (HYLAN G-F 20
FDA premarket approval P940015/S001 · decided 1998-11-05
Approval details
- PMA number
- P940015
- Supplement
- S001
- 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
- 1998-09-29
- Decision date
- 1998-11-05
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for labeling changes, including addition of the statement: "The packaging of this product contains dry natural rubber latex."
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