SINOVIAL (SODIUM HYALURONATE 0.8%)
FDA premarket approval P110005 · decided 2014-05-09
Approval details
- PMA number
- P110005
- Trade name
- SINOVIAL (SODIUM HYALURONATE 0.8%)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ibsa Institut Biochimique SA
- Date received
- 2011-02-10
- Decision date
- 2014-05-09
- Days to decision
- 1184 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lugano Ticino
- Statement
- APPROVAL FOR GEL-SYN. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS (E.G. ACETAMINOPHEN).
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