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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 NumberS011
Date Received12/08/2009
Decision Date12/22/2009
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Introduction of an additional piece of equipment for testing in-process control (ipc) and finished product samples.
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