BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S058 · Decision Nov 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MEDTRONIC IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR SYSTEMS ENTRUST ICOS
    PMA Number
    P980016
    Supplement Number
    S058
    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 15, 2005
    Date Received
    October 5, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) MEDTRONIC MODEL 2490G CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DDMA SOFTWARE TO SUPPORT THE ENTRUST ICDS 2) TO MAKE OPTIVOL INFORMATION WITHOUT THE THRESHOLD LINE AVAILABLE FOR INSYNC SENTRY MODELS 7297 AND 7299 VIEWABLE BY PHYSICIANS USING THE CARELINK NETWORK.

    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)