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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceSYNOJOYNT
Generic Nameacid, hyaluronic, intraarticular
ApplicantArthrex, Inc
1370 creekside boulevard
naples, FL 34108-1945
PMA NumberP170016
Date Received05/15/2017
Decision Date05/08/2018
Product Code MOZ 
Docket Number 18M-1753
Notice Date 05/22/2018
Advisory Committee Orthopedic
Clinical TrialsNCT02495857
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for SYNOJOYNT. SYNOJOYNT is indicated for use in 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  
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