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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.
 
DeviceTRIVISC
Generic Nameacid, hyaluronic, intraarticular
ApplicantORTHOGENRX,INC
3805 old easton road
doylestown, PA 18902-8400
PMA NumberP160057
Date Received12/23/2016
Decision Date11/13/2017
Product Code MOZ 
Docket Number 17M-6525
Notice Date 11/21/2017
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for TriVisc. The 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 
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