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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEUFLEXXA (1% SODIUM HYALURONATE)
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, hyaluronic,intraarticular
ApplicantFERRING PHARMACEUTICALS, INC.
PMA NumberP010029
Supplement NumberS008
Date Received05/04/2009
Decision Date10/11/2011
Product Code
MOZ[ Registered Establishments with MOZ ]
Docket Number 11M-0736
Notice Date 10/20/2011
Advisory Committee Orthopedic
Clinical Trials NCT00379236
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for euflexxa (1% sodium hyaluronate). This 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
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