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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
ApplicantQ-MED SCANDINAVIA, INC.
PMA NumberP000029
Supplement NumberS051
Date Received10/06/2008
Decision Date10/22/2008
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the deflux package insert to minimize the incidence of syringe breakage and resulting treatment interruptions.
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