BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P920014 · Supplement: S015 · Decision May 31, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    HEARTMATE XVE LVAS
    PMA Number
    P920014
    Supplement Number
    S015
    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
    May 31, 2001
    Date Received
    February 23, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO INCLUDE THE HEARTMATE. XVE LVAS UNDER P920014, WITH THE SAME INDICATIONS FOR USE AS FOR THE PREVIOUSLY APPROVED (IN SUPPLEMENT S7, APPROVAL LETTER DATED OCTOBER 6, 1998) VE LVAS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEARTMATE. XVE LVAS AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE. THE HEARTMATE. SVE LVAS IS INDICATED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.

    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