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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 AB
PMA NumberP000029
Supplement NumberS002
Date Received11/22/2002
Decision Date12/18/2002
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 
Change in site for bacterial endotoxin testing for the deflux needle, a component of the deflux device. The testing is currently conducted at a contract facility, namsa, and will be moved to q-med's microbiology qc laboratory in uppsala, sweden. There will also be a change of test method from kinetic-chromogenic lal procedure to the gel clot lal test.
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