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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTriVisc
Generic NameAcid, hyaluronic, intraarticular
ApplicantORTHOGENRX,INC
3805 OLD EASTON ROAD
DOYLESTOWN, PA 18902-8400
PMA NumberP160057
Supplement NumberS001
Date Received05/08/2020
Decision Date06/07/2020
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for revision of the instructions for administration of TriVisc to help prevent any leakage of the product during administration.
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