BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P920014 · Supplement: S017 · Decision Apr 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORETEC HEARTMATE XVE LVAS
    PMA Number
    P920014
    Supplement Number
    S017
    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
    April 4, 2003
    Date Received
    November 12, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN EXPANDED INDICATION FOR USE FOR THE THORATEC HEARTMATE XVE LVAS. THIS DEVICE SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE. IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION CLASS IV END STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 60 OF THE LAST 90 DAYS, AND WHO HAVE A LIFE EXPECTANCY OF LESS THAN TWO YEARS, AND WHO ARE NOT ELIGIBLE FOR CARDIAC TRANSPLANTATION. THE DEVICE SYSTEM IS APPROVED 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