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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSINOVIAL (SODIUM HYALURONATE 0.8%)
Classification Nameacid, hyaluronic, intraarticular
ApplicantIBSA INSTITUT BIOCHIMIQUE SA
PMA NumberP110005
Date Received02/10/2011
Decision Date05/09/2014
Product Code
MOZ[ Registered Establishments with MOZ ]
Docket Number 14M-0691
Notice Date 05/29/2014
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order 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).
Approval Order Approval Order
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