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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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
Supplement NumberS076
Date Received11/13/2023
Decision Date02/08/2024
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the expansion to 1.5T MRI conditional labeling for patients who have the Axonics Sacral Neuromodulation System with an existing Medtronic Sacral Neuromodulation lead fragment.
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