SYNVISC (HYLAN G-F 20)
FDA premarket approval P940015/S004 · decided 1999-05-26
Approval details
- PMA number
- P940015
- Supplement
- S004
- 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
- 1999-05-03
- Decision date
- 1999-05-26
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for labeling changes to the Physician Package Insert. The device, as modified, will be marketed under the trade name Synvisc(R) (Hylan G-F 20) and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen.
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