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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDEFLUX INJECTABLE GEL REN
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameinjectable bulking agent
ApplicantSALIX PHARMACEUTICALS, INC.
PMA NumberP000029
Date Received07/11/2000
Decision Date09/24/2001
Product Code
LNM[ Registered Establishments with LNM ]
Docket Number 01M-0439
Notice Date 10/01/2001
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for deflux injectable gel. The device is indicated for treatment of children with vesicoureteral reflux (vur) grades ii-iv.
Approval Order Approval Order
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S039 S040 S041 S042 S043 S044 S045 S046 S047 
S049 S050 S051 S052 S053 S055 S056 S057 S058 
S059 S060 S061 S062 S063 S064 S065 S066 S067 
S069 S070 S071 S072 S073 S074 S075 S076 S077 
S078 S079 
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