BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P870072 · Supplement: S024 · Decision Dec 31, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
    PMA Number
    P870072
    Supplement Number
    S024
    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
    December 31, 2002
    Date Received
    December 11, 2002
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A WARNING STATEMENT TO THE PACKAGE LABELS AND TO THE INSTRUCTIONS FOR USE FOR THE BEVELED-TIP ATRIAL CANNULA, AS USED WITH THE THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM.

    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