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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 NameNUXFLEXXA (SODIUM HYALURONATE)
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantFERRING PHARMACEUTICALS, INC.
PMA NumberP010029
Supplement NumberS001
Date Received02/16/2005
Decision Date02/27/2006
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) changing the storage conditions specified in the product labeling from, ?store in a cold dark place [2 ? 8 degrees c (36-46 degrees f)]. Protect from light. Do not freeze?. 2) change the specified shelf life time in the labeling form 3 years (at refrigerated temperatures) to 12 months. The device, as modified, will be marketed under the trade name euflexxa and 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. ).
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