BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P920014 · Supplement: S013 · Decision Oct 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    TCI HEARTMATE VE LVAS
    PMA Number
    P920014
    Supplement Number
    S013
    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
    October 20, 2000
    Date Received
    September 15, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE HEARTMATE VE SYSTEM CONTROLLER (C/N 1215) TO ACCOMODATE A NEW FOUR CELL BATTERY MODULE (BATTERY CELL), RESULTING IN VE SYSTEM CONTROLLER C/N 1216 AND BATTERY MODULE C/N 1264.

    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