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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 NumberS057
Date Received09/30/2009
Decision Date10/30/2009
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of the sanitization process for the water for injection (wfi) and purified water (pw) systems and to reduce the frequency of certain periodic reviews.
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