BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S881 · Decision May 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD,
    PMA Number
    P980016
    Supplement Number
    S881
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 9, 2024
    Date Received
    February 9, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for manufacturing and design changes to Resistor Array Network (RAN) components used in select ICD and CRT-D devices.

    Classifications

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

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)