PMA P200036

Device: eCoin Peripheral Neurostimulator
Applicant: Boston Scientific Corporation
PMA number: P200036
Supplement: S004
Product code: QPT
Decision date: 2026-03-03
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Approval order statement: Approval for protocol revisions which clarified the definition of subject enrollment and updates to the Schedule of Activities table regarding follow-up phone calls and clarification of protocol-unrelated standards of clinical care.

Current openFDA PMA Record#

Device: eCoin Peripheral Neurostimulator
Applicant: Boston Scientific Corporation
PMA number: P200036
Supplement: S010
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2026-03-03
Decision code: APPR
Date received: 2026-02-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval for protocol revisions which clarified the definition of subject enrollment and updates to the Schedule of Activities table regarding follow-up phone calls and clarification of protocol-unrelated standards of clinical care.