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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.
 
DeviceEuflexxa (1% Sodium Hyaluronate)
Generic Nameacid, hyaluronic, intraarticular
ApplicantFERRING PHARMACEUTICALS, INC.
100 interpace parkway
parsippany, NJ 07054
PMA NumberP010029
Supplement NumberS026
Date Received03/29/2018
Decision Date04/26/2018
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modification to a purification step for a sodium hyaluronate intermediate used to manufacture EUFLEXXA.
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