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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 Implant Tibial Stimulator
Generic NameStimulator, tibial, electrical, implantable, for urinary incontinence
ApplicantBoston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP200036
Supplement NumberS004
Date Received10/31/2022
Decision Date11/30/2022
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 of the revised protocol for the post-approval study (PAS) - A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
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