eCoin Peripheral Neurostimulator

FDA premarket approval P200036 · Stimulator, tibial, electrical, implantable, for urinary incontinence

PMA numberP200036

Approval

Applicant
Boston Scientific Corporation
Received
August 10, 2020
Decision date
March 1, 2022 (APPR)
Supplements
10, latest September 9, 2026
Product code
QPT – Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

Official FDA PMA record

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.