BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P870072 · Supplement: S010 · Decision Nov 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM
    PMA Number
    P870072
    Supplement Number
    S010
    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
    November 15, 2000
    Date Received
    April 11, 2000
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SURGICAL IMPLANT ACCESSORY KIT WITH THE FOLLOWING ACCESSORIES: VENTRICULAR CANNULA VENTING CONNECTOR, VALVE HOUSING CAPS, CANNULA PLUGS, ATRIAL CANNULA TIP CAP, AND Y-CONNECTOR CAP. THE ACCESSORY KIT WILL BE MANUFACTURED AT HORIZON MEDICAL, INC., SANTA ANA, CALIFORNIA, AND STERILIZED BY STERIGENICS, TUSTIN, CALIFORNIA.

    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