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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)
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, hyaluronic, intraarticular
Applicant
FERRING PHARMACEUTICALS, INC.
100 interpace parkway
parsippany, NJ 07054
PMA NumberP010029
Date Received05/01/2001
Decision Date12/03/2004
Product Code
MOZ[ Registered Establishments with MOZ ]
Docket Number 06M-0338
Notice Date 08/24/2006
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 
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