eCoin (Electroceutical Coin)

FDA Premarket Approval P200036 S003

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.

Pre-market Approval Supplement Details

DeviceeCoin (Electroceutical Coin)
Generic NameStimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
ApplicantValencia Technologies Corporation28464 Westinghouse Placevalencia, 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
Date Received2022-04-26
Decision Date2022-07-15
PMAP200036
SupplementS003
Product CodeQPT 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressValencia 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.

Supplemental Filings

Supplement NumberDateSupplement Type
P200036Original Filing
S003 2022-04-26 Normal 180 Day Track No User Fee
S002
S001

NIH GUDID Devices

Device IDPMASupp
00860007896965 P200036 000
00860007896910 P200036 000
00860007896903 P200036 000

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