BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S354 · Decision Oct 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK
    PMA Number
    P890003
    Supplement Number
    S354
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 12, 2016
    Date Received
    April 15, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable