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eCoin Peripheral Neurostimulator

by Boston Scientific

PMA P200036

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P200036↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP200036 Date1 Mar 2022ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic name
Stimulator, tibial, electrical, implantable, for urinary incontinence
FDA applicant
Boston Scientific Corporation
PMA number
FDA product code
QPT
Device class
Class III
Advisory committee
Gastroenterology, Urology
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The eCoin Peripheral Neurostimulator is an implantable electrical stimulator designed to treat urgency urinary incontinence. Classified as a tibial electrical stimulator, it targets patients who are intolerant to or inadequately responsive to conservative treatments, or those who have previously benefited from percutaneous tibial nerve stimulation trials.

This device is implanted surgically and delivers electrical stimulation to the tibial nerve to modulate urinary urgency. Supplied sterile and intended for single-use implantation, it is regulated under FDA Premarket Approval (PMA P200036) and falls under Class III device classification (QPT product code). Multiple FEI numbers (e.g., 3018094310) correspond to its regulatory filings.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary medical condition the eCoin Peripheral Neurostimulator is intended to treat, and who is it designed for?

    The eCoin Peripheral Neurostimulator is designed to treat **urgency urinary incontinence** in patients who are either intolerant to or inadequately responsive to conservative treatments. It is also intended for patients who have previously shown benefit from **percutaneous tibial nerve stimulation trials**, as it delivers electrical stimulation to the tibial nerve to help modulate urinary urgency.

  • How is the eCoin Peripheral Neurostimulator supplied, and is it meant for single-use or reusable applications?

    The eCoin Peripheral Neurostimulator is supplied **sterile** and is explicitly intended for **single-use implantation**. This means it is not designed for reuse after initial surgical placement.

  • What regulatory pathway was followed for the approval of this device, and what classification does it hold?

    The eCoin Peripheral Neurostimulator underwent **FDA Premarket Approval (PMA P200036)**, which is a rigorous review process for high-risk medical devices. It is classified as a **Class III device** under the **QPT product code**, indicating it requires this level of scrutiny due to its implantable nature and intended therapeutic use.

  • Does this device require any specific storage conditions, and how is it typically implanted?

    The device is **sterile upon supply**, so it should be stored according to standard sterile medical device protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures. It is **implanted surgically**, meaning it requires a trained medical professional to place it under the skin near the tibial nerve to deliver targeted electrical stimulation.