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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 NumberS011
Date Received10/28/2004
Decision Date11/12/2004
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN INCREASE IN THE SHELF LIFE OF DX-10 FROM 6 MONTHS TO 12 MONTHS.
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