BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010012 · Supplement: S176 · Decision Apr 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) MODELS H220, H225, H227, AND H229
    PMA Number
    P010012
    Supplement Number
    S176
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 17, 2008
    Date Received
    March 12, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN UPDATED HEADER CONFIGURATION FOR THE CONFIENT AND LIVIAN DEVICE FAMILIES TO INCLUDE CHANGED SETSCREWS, SEAL PLUGS, AND LEFT VENTRICULAR RING LEAD WIRE ROUTING (LIVIAN ONLY) AS WELL AS THE ADDITION OF A NEW MODEL TORQUE WRENCH.

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)