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

    Permanent Defibrillator Electrodes

    PMA: P240036 · Supplement: S003 · Decision Oct 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    OmniaSecure™ MRI SureScan™ Lead Model 3930M
    PMA Number
    P240036
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    NVY
    Generic Name
    Permanent defibrillator electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 30, 2025
    Date Received
    September 30, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    allow a manufacturing supplier site change for the wire coil component of the Omnia Secure lead.

    Classifications

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

    Product Code Device Name
    NVY Permanent Defibrillator Electrodes