BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pacemaker/Icd/Crt Non-Implanted Components

    PMA: P890003 · Supplement: S284 · Decision Oct 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Pacemaker/Icd/Crt Non-Implanted Components
    Trade Name
    REVEAL DX, REVEAL XT
    PMA Number
    P890003
    Supplement Number
    S284
    Device Class
    FDA Class 3
    Product Code
    OSR
    Generic Name
    Pacemaker/icd/crt non-implanted components
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 15, 2013
    Date Received
    August 12, 2013
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES.

    Classifications

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

    Product Code Device Name
    OSR Pacemaker/Icd/Crt Non-Implanted Components