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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
ApplicantBoston Scientific Corporation
100 Boston Scientfic Way
Marlborough, MA 01752
PMA NumberP190006
Supplement NumberS025
Date Received11/04/2020
Decision Date06/11/2021
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of "3T RF whole-body coil conditional MRI scans at MC 2 mode" labeling on the Axonics Sacral Neuromodulation System.
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