BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P870072 · Supplement: S027 · Decision Aug 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
    PMA Number
    P870072
    Supplement Number
    S027
    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
    August 3, 2004
    Date Received
    January 6, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) AS AN ALTERNATE VAD BLOOD PUMP FOR USE IN THE APPROVED THORATEC VENTRICULAR ASSIST DEVICE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE AND IS INDICATED FOR USE IN BRIDGE TO TRANSPLANT PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA: CANDIDATE FOR CARDIAC TRANSPLANTATION, IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, DEPENDENCE ON, OR INCOMPLETE RESPONSE TO, CONTINUED VASOPRESSOR SUPPORT. IT IS ALSO INDICATED FOR POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. IN ADDITION, THE IVAD IS DESIGNED TO BE COMPATIBLE WITH BOTH THE DUAL DRIVER CONSOLE AND TLC-II PORTABLE VAD DRIVER.

    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