PMA P200036S003

Device: eCoin (Electroceutical Coin)
Applicant: Boston Scientific Corporation
PMA number: P200036
Supplement: S003
Product code: QPT
Decision date: 2022-07-15
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
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.

Current openFDA PMA Record#

Device: eCoin (Electroceutical Coin)
Applicant: Boston Scientific Corporation
PMA number: P200036
Supplement: S003
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2022-07-15
Decision code: APPR
Date received: 2022-04-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.