BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P920015 · Supplement: S281 · Decision Nov 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    HV Splitter/Adaptor kit
    PMA Number
    P920015
    Supplement Number
    S281
    Device Class
    FDA Class 3
    Product Code
    NVY
    Generic Name
    Permanent defibrillator electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 13, 2023
    Date Received
    August 16, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    a change in sterilization cycle parameters used for routine product sterilization

    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