BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P060040 · Decision Apr 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
    PMA Number
    P060040
    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 21, 2008
    Date Received
    December 22, 2006
    Expedited Review
    N
    Docket Number
    08M-0283

    Advisory Committee Statement

    APPROVAL FOR THE THORATEC HEARTMATE II LVAS. THIS DEVICE IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NON-REVERSIBLE LEFT VENTRICULAR FAILURE. THE HEARTMATE II LVAS IS INTENDED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL, OR FOR TRANSPORTATION OF VENTRICULAR ASSIST DEVICE PATIENTS VIA GROUND AMBULANCE, FIXED-WING AIRCRAFT, OR HELICOPTER.

    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