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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
Applicant
Axonics Modulation Technologies, Inc.
26 technology drive
irvine, CA 92618
PMA NumberP190006
Date Received03/04/2019
Decision Date09/06/2019
Product Code 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
Supplements:  S001 S002 S003 S004 S005 S007 S008 S009 
S010 
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