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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 NameDEFLUX INJECTABLE GEL
Classification Nameagent, bulking, injectable for gastro-urology use
ApplicantOCEANA THERAPEUTICS INC
PMA NumberP000029
Supplement NumberS065
Date Received02/22/2010
Decision Date06/01/2010
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the sterilization method to gamma radiation, changing the packaging materials, and outsourcing the manufacturing of the deflux needle component.
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