BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P870072 · Supplement: S035 · Decision Jan 21, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    TLC-II PORTABLE VAD DRIVER
    PMA Number
    P870072
    Supplement Number
    S035
    Device Class
    FDA Class 3
    Product Code
    DSQ
    Generic Name
    Ventricular (assist) bypass
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 21, 2009
    Date Received
    September 14, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE TLC-II PORTABLE VAD DRIVER, INCLUDING THE ADDITION OF A SCROLL COMPRESSOR, ELECTRONIC RVAD PRESSURE REGULATOR, LONGER PNEUMATIC LEADS REMOVAL OF CONTRAINDICATION AGAINST PATIENTS REQUIRING HIGH RVAD DRIVER PRESSURES AND/OR LONG EJECTION TIMES, AND ASSOCIATED HARDWARE AND SOFTWARE CHANGES.

    Classifications

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

    Product Code Device Name
    DSQ Ventricular (Assist) Bypass