SYNVISC HYLAN G-F 20
FDA premarket approval P940015/S011 · decided 2008-06-09
Approval details
- PMA number
- P940015
- Supplement
- S011
- Supplement type
- Normal 180 Day 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
- 2007-02-20
- Decision date
- 2008-06-09
- Days to decision
- 475 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR THE REPLACEMENT OF THE DILUTION STATEMENT FROM THE ?PRECAUTION? SECTION AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
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