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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameEUFLEXXA (1% SODIUM HYALURONATE)
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantFERRING PHARMACEUTICALS, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S004 S006 S007 S008 
S009 S010 S011 S012 S013 S014 
S015 S016 
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