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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 NumberS006
Date Received03/22/2007
Decision Date07/11/2007
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a syringe tip cap material change from natural rubber to a synthetic rubber formulation.
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