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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDEFLUX INJECTABLE GEL
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameagent, bulking, injectable for gastro-urology use
Applicant
VALEANT PHARMACEUTICALS NORTH AMERICA, LLC
400 somerset corporate boulevard
bridgewater, NJ 08807
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 - manufacturer/sterilizer/packager/supplier
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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