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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 Peripheral Neurostimulator
Generic NameStimulator, tibial, electrical, implantable, for urinary incontinence
ApplicantBoston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP200036
Supplement NumberS008
Date Received06/20/2025
Decision Date07/16/2025
Product Code QPT 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT05685433
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for PAS protocol revisions including the addition of sites
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