BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980023 · Supplement: S035 · Decision Nov 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
    PMA Number
    P980023
    Supplement Number
    S035
    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
    November 21, 2008
    Date Received
    October 31, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPDATES TO THE HOME MONITORING SERVICE CENTER USED WITH THE PHILOS II AND CYLOS FAMILIES OF PULSEGENERATORS LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. STRATOS LV-TPULSE GENERATOR. CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND THE KRONOS LV-T AND LUMAX FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.

    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)