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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
Classification Nameagent, bulking, injectable for gastro-urology use
ApplicantSALIX PHARMACEUTICALS, INC.
PMA NumberP000029
Supplement NumberS072
Date Received03/30/2012
Decision Date04/12/2012
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 
Addition of the possibility to store samples for bioburden analysis in a refrigerator at a temperature of 5 degree celsius for up to 18 hours before analysis.
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