PMA P200036S001

Device: eCoin Peripheral Neurostimulator
Applicant: Boston Scientific Corporation
Product code: QPT
Decision date: 2022-08-17
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
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.

Current openFDA PMA Record#

Device: eCoin Peripheral Neurostimulator
Applicant: Boston Scientific Corporation
PMA number: P200036
Supplement: S001
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2022-08-17
Decision code: APPR
Date received: 2022-03-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.