BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P050023 · Supplement: S166 · Decision Apr 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    PSW 2201.U/1 and NEO 2201.U/1
    PMA Number
    P050023
    Supplement Number
    S166
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 11, 2022
    Date Received
    February 7, 2022
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updated programmer software versions PSW 2201.U/1 and NEO 2201.U/1.

    Classifications

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

    Product Code Device Name
    MRM Defibrillator, Implantable, Dual-Chamber