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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.
 
DeviceAxonics Sacral Neuromodulation System
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantBoston Scientific Corporation
100 BOSTON SCIENTFIC WAY
MARLBOROUGH, MA 01752
PMA NumberP180046
Date Received12/06/2018
Decision Date11/13/2019
Product Code EZW 
Docket Number 19M-5393
Notice Date 11/14/2019
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT03327948
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Axonics Sacral Neuromodulation System. The device is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S042 S043 S044 S051 S011 S013 S061 S062 S063 S036 S037 S027 
S021 S015 S016 S017 S018 S019 S020 S005 S066 S067 S068 S071 
S072 S073 S084 S090 S091 S092 S077 S078 S079 S080 S022  
S001 S002 S003 S004 S006 S007 S008 S009 S010 S056 S057 S032 
S033 S034 S023 S024 S025 S026 S059 S060 S038 S052 S054 S055 
S045 S046 S047 S049 S050 S041 S029 S030 S031 S064 S065 S097 
S074 S087 S088 S089 S081 S082 S083 S093 S094 S095 S096 S098 
S075 S076 S085 S086 S069 
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