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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 NameImplanted electrical device intended for treatment of fecal incontinence
Regulation Number876.5270
ApplicantAxonics Modulation Technologies, Inc.
26 Technology Drive
Irvine, CA 92618
PMA NumberP190006
Supplement NumberS002
Date Received10/18/2019
Decision Date12/12/2019
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the Charging Device (CD), model 1401, which included a new rechargeable Li-ion battery, a new speaker, and corresponding software changes.
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