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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEUFLEXXA (1% SODIUM HYALURONATE)
Generic NameAcid, hyaluronic, intraarticular
ApplicantFERRING PHARMACEUTICALS, INC.
100 INTERPACE PARKWAY
PARSIPPANY, NJ 07054
PMA NumberP010029
Date Received05/01/2001
Decision Date12/03/2004
Product Code MOZ 
Docket Number 06M-0338
Notice Date 08/24/2006
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR NUFLEXXA (1% SODIUM HYALURONATE). 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).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S004 S006 S007 S008 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S032 S033 S034 S035 S036 S037 S038 
S039 S040 
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