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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 NumberS037
Date Received02/05/2024
Decision Date03/01/2024
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  
modifications to the purification process utilized in the manufacturing of NaHA bulk intermediate batches to optimize the ability to remove contaminants and to improve yield. Proposed modifications include increasing the amount of activated charcoal, Celatom and water for injection for the 1 kg and 1.5 kg batch sizes as well as two additional ethanol washes for the 1.5 kg batch size
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