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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceAxonics Sacral Neuromodulation System
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Axonics Modulation Technologies, Inc.
26 technology drive
irvine, CA 92618
PMA NumberP190006
Date Received03/04/2019
Decision Date09/06/2019
Product Code
EZW[ Registered Establishments with EZW ]
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2