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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 Pkwy.
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
Predetermined Change Control Plan AuthorizedNo
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:  S012 S001 S016 S007 S002 S006 S009 S008 S010 S011 S025 
S030 S032 S033 S035 S040 S037 S042 S026 S027 S028 S038 S036 
S004 S022 S023 S015 S019 S018 S024 S013 S017 S020 S021 S029 
S014 S034 S041 S039 
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