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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.
 
DeviceeCoin Tibial Nerve Stimulator System
Generic NameStimulator, tibial, electrical, implantable, for urinary incontinence
ApplicantBoston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP200036
Supplement NumberS009
Date Received09/10/2025
Decision Date10/02/2025
Product Code QPT 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change in supplier for the Printed Circuit Board Assembly (PCBA)
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