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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
ApplicantBoston Scientific Corporation
100 Boston Scientfic Way
Marlborough, MA 01752
PMA NumberP180046
Supplement NumberS026
Date Received11/05/2020
Decision Date02/03/2021
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an update to the software and associated labeling for the Model 1101 implantable neurostimulator and Model 2501 clinician programmer to support the use of two therapy programs.
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