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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
Generic Nameinjectable bulking agent
ApplicantQ-MED SCANDINAVIA, INC.
PMA NumberP000029
Supplement NumberS007
Date Received03/23/2004
Decision Date04/21/2004
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 
Changes to the accessory device, the deflux metal needle, to include addition of bioburden and sterility testing and to remove the bioindicator usage during ordinary manufacturing.
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