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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
ApplicantAxonics Modulation Technologies, Inc.
26 technology drive
irvine, CA 92618
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
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:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S013 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S029 S030 S031 S032 S033 S034 S036 S037 S038 S041 
S042 S043 S044 S045 S046 S047 S049 S050 S051 S052 S055 S057 
S059 S060 S061 
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