BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    PMA: P080025 · Supplement: S285 · Decision Dec 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
    Trade Name
    InterStim Therapy System, Verify Evaluation System
    PMA Number
    P080025
    Supplement Number
    S285
    Device Class
    FDA Class 3
    Product Code
    QON
    Generic Name
    Implanted electrical device intended for treatment of fecal incontinence
    Regulation Number
    876.5270
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 18, 2023
    Date Received
    September 28, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    for labeling updates to the MRI Guidelines manual. The proposed labeling updates are to add the following: 1. MRI eligibility (full-body scans at 1.5T, 3T) criteria for abandoned lead fragments that may remain behind when explant is attempted. 2. MRI eligibility (head-only scans at 1.5T) criteria for a confirmed non-functional primary cell (non-rechargeable) implantable neurostimulator from Medtronic

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence