BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980023 · Supplement: S002 · Decision Sep 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    PHYLAX 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM
    PMA Number
    P980023
    Supplement Number
    S002
    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
    September 13, 1999
    Date Received
    June 1, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for device hardware and software modifications. The device, as modified, will be marketed under the trade name mycroPhylax(Plus), Phylax XM, and TMS 1000(Plus) Tachyarrhythmia Monitoring System. The devices are indicated for use in patients who are at risk of sudden death due to ventriular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmias; or recurrent poorly tolerated sustained ventricular tachycardia (VT).

    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)