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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 NumberS025
Date Received06/20/2017
Decision Date12/28/2017
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for BTG (Ferring) to manufacture, package and release Euflexxa at both the BTG (Ferring) and Lifecore facilities.
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