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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 Pkwy.
Parsippany, NJ 07054
PMA NumberP010029
Supplement NumberS030
Date Received04/02/2020
Decision Date04/16/2020
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change in manufacturing to shorten the time required for the concentration step during formulation by slightly increasing the pressure and reducing the concentration time in the UF (ultrafiltration) unit.
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