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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTRILURON
Generic NameAcid, hyaluronic, intraarticular
ApplicantFidia Farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
Abano Terme 35031
PMA NumberP180040
Date Received09/27/2018
Decision Date03/26/2019
Product Code MOZ 
Docket Number 19M-1465
Notice Date 03/28/2019
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for TRILURON. The device 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:  S002 S003 S004 
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