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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 NumberS012
Date Received04/08/2005
Decision Date08/02/2005
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFICATION OF THE POST APPROVAL STUDY PROTOCOL TO: 1) REPLACE THE 1- AND 5-YEAR VOIDING CYSTOURETHROGRAM MEASUREMENTS WITH CLINICAL ASSESSMENTS OF "FEBRILE UTI;" AND 2) DECREASE THE TOTAL SAMPLE SIZE FROM 200 TO 149 PATIENTS.
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