BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P870072 · Supplement: S034 · Decision Jun 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM
    PMA Number
    P870072
    Supplement Number
    S034
    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
    June 28, 2007
    Date Received
    July 12, 2006
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MATERIAL CHANGE IN THE TUBING THAT CONNECTS THE BODY OF THE PARACORPOREAL THORATEC VENTRICULAR ASSIST DEVICE WITH THE METAL Y-CONNECTOR THAT SPLITS THE LINE INTO SEPARATE ELECTRICAL AND PNEUMATIC CONNECTIONS.

    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