BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Electrical, Implantable, For Incontinence

    PMA: P970004 · Supplement: S431 · Decision Aug 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Electrical, Implantable, For Incontinence
    Trade Name
    InterStim™ Therapy System, Verify™ Evaluation System
    PMA Number
    P970004
    Supplement Number
    S431
    Device Class
    FDA Class 3
    Product Code
    EZW
    Generic Name
    Stimulator, electrical, implantable, for incontinence
    Regulation Number
    876.5270
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 1, 2025
    Date Received
    July 24, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the implementation of Corrective Action Preventive Action (CAPA) recommended corrective/preventative actions to improve the manufacturing process of the Delta 26H2 and 26H3 batteries at Medtronic’s internal supplier – Medtronic Energy and Component Center (MECC) in Brooklyn Center, Minnesota

    Classifications

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

    Product Code Device Name
    EZW Stimulator, Electrical, Implantable, For Incontinence