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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 NumberS015
Date Received04/05/2012
Decision Date05/04/2012
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of a new filling machine.
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