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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
Generic NameAcid, hyaluronic, intraarticular
ApplicantFERRING PHARMACEUTICALS, INC.
100 INTERPACE PARKWAY
PARSIPPANY, NJ 07054
PMA NumberP010029
Supplement NumberS038
Date Received03/07/2024
Decision Date04/06/2024
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 updating the syringe label to include the symbol for a single barrier system with protective packaging outside.
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