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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDEFLUX INJECTABLE GEL
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantPalette Life Sciences
27 East Cota Street
Suite 402
Santa Barbara, CA 93101
PMA NumberP000029
Date Received07/11/2000
Decision Date09/24/2001
Product Code LNM 
Docket Number 01M-0439
Notice Date 10/01/2001
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DEFLUX INJECTABLE GEL. THE DEVICE IS INDICATED FOR TREATMENT OF CHILDREN WITH VESICOURETERAL REFLUX (VUR) GRADES II-IV.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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 S080 S081 S082 S083 S084 S085 S086 S087 S088 
S089 S090 S091 S092 S093 S094 S095 S096 S097 
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