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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 (Electroceutical Coin)
Generic NameStimulator, tibial, electrical, implantable, for urinary incontinence
ApplicantValencia Technologies Corporation
28464 Westinghouse Place
Valencia, CA 91355
PMA NumberP200036
Supplement NumberS003
Date Received04/26/2022
Decision Date07/15/2022
Product Code QPT 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT03556891
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the eCoin® Peripheral Neurostimulator. The device is intended to be used to treat urgency urinary incontinence in patients intolerant to or having an inadequate response to other more conservative treatments or who have undergone a successful trial of percutaneous tibial nerve stimulation.
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