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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceTRILURON
Generic Nameacid, hyaluronic, intraarticular
Applicant
Fidia 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 Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements:  
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