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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 NumberS002
Date Received10/05/2005
Decision Date10/20/2005
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR CHANGING THE TRADE NAME O THE PRODUCT FROM NUFLEXXA TO EUFLEXXA. THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
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