BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S297 · Decision Jul 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    CARELINK ENORE PROGRAMMER,CARELINK 2090 PROGRAMMER,CARELINK HOME MONITOR,CARELINK EXPRESS MONITOR,CARDIOSIGHT READER,DEV
    PMA Number
    P890003
    Supplement Number
    S297
    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
    July 9, 2014
    Date Received
    December 18, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC VIVA CRT-P MODEL C6TR01 IMPLANTABLEPACEMAKER WITH CARDIAC RESYNCHRONIZATION; PROGRAMMER SOFTWARE APPLICATION MODEL 9995 V8.3; AND UPDATES TO THE MEDTRONIC CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL2020A AND CARELINK EXPRESS MODEL 2020B FIRMWARE, AND TO THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA).

    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