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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 NumberS001
Date Received03/30/2022
Decision Date08/17/2022
Product Code QPT 
Advisory Committee Gastroenterology/Urology
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 the Post-Approval Study of eCoin® for treatment of urgency urinary incontinence (UUI) which is designed to collect effectiveness and safety data in a post-approval setting.
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