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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 Nameimplanted electrical device intended for treatment of fecal incontinence
Regulation Number876.5270
Applicant
Axonics Modulation Technologies, Inc.
26 technology drive
irvine, CA 92618
PMA NumberP190006
Date Received03/04/2019
Decision Date09/06/2019
Product Code QON 
Docket Number 19M-4186
Notice Date 09/30/2019
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT03327948
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Axonics Sacral Neuromodulation System. This device is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for 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 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S029 
S030 S031 S032 S033 S034 S036 S037 S042 S043 
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