BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S021 · Decision Dec 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE
    PMA Number
    P980016
    Supplement Number
    S021
    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
    December 21, 2001
    Date Received
    September 6, 2001
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 2490A CARELINK MONITOR WITH MODEL 2491 DDMA SERVER-RESIDENT SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL 2490A CARELINK MONITOR AND IS INDICATED FOR USE IN THE TRANSFER OF PATIENT DATA FROM MEDTRONIC GEM II ICDS (GEM II VR MODEL 7229 AND GEM II DR MODEL 7273).

    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)