BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P870072 · Supplement: S060 · Decision Jun 4, 2015
    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
    S060
    Device Class
    FDA Class 3
    Product Code
    DSQ
    Generic Name
    Ventricular (assist) bypass
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 4, 2015
    Date Received
    May 7, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF A SUPPLIERS FACILITY RELOCATION FOR CERTAIN COMPONENTS OF THE THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM AND THORATEC VENTRICULAR ASSIST DEVICE 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