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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 NumberS046
Date Received05/27/2008
Decision Date06/25/2008
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES IN THE PRECAUTIONS AND DIRECTIONS FOR USE SECTIONS OF THE PACKAGE INSERT.
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