BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P920014 · Supplement: S023 · Decision Jul 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
    PMA Number
    P920014
    Supplement Number
    S023
    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
    July 8, 2004
    Date Received
    January 9, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF THE POWERSONIC SEALED LEAD ACID BATTERY (MODEL PS-1223) AS A REPLACEMENT FOR THE NO LONGER MANUFACTURED PANASONIC SEALED LEAD ACID BATTERY (MODEL LC-SA122R3EU) AS A SOURCE OF BATTERY POWER TO DRIVE THE HEARTMATE VE AND ZVE LEFT VENTRICULAR ASSIST SYSTEMS.

    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