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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 NumberS007
Date Received05/12/2008
Decision Date07/01/2009
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the sterile sodium hyaluronate (naha) to be stored in sterile, disposable polyethylene bags for up to 48 hours prior to filling the syringes. The device, as modified, will be marketed under the trade name euflexxa and is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e. G. , acetaminophen.
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