BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    PMA: P850051 · Supplement: S022 · Decision Oct 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Pulse-Generator, Single Chamber, Sensor Driven, Implantable
    Trade Name
    LEGEND MODELS 8416/8417/8418,ST MODELS 8406/8407
    PMA Number
    P850051
    Supplement Number
    S022
    Device Class
    FDA Class 3
    Product Code
    LWO
    Generic Name
    Pulse-generator, single chamber, sensor driven, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 18, 1989
    Date Received
    August 18, 1989
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable