BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implantable, For Incontinence

    PMA: P240031 · Supplement: S001 · Decision Aug 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Electrical, Implantable, For Incontinence
    Trade Name
    Neuspera Sacral Neuromodulation System
    PMA Number
    P240031
    Supplement Number
    S001
    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
    Approved
    Decision Code
    APPR
    Decision Date
    August 15, 2025
    Date Received
    July 18, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    approval of the protocol for the post-approval study (PAS) of Neuspera Sacral Neuromodulation System.

    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