BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P060040 · Supplement: S007 · Decision Apr 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORATEC HEARTMATE 2 LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
    PMA Number
    P060040
    Supplement Number
    S007
    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
    April 6, 2010
    Date Received
    March 25, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A REPAIR KIT (HM II PLRK) FOR THE EXTERNAL PORTION OF THE HEARTMATE II PERCUTANEOUS LEAD AND A REPAIR KIT (CLAM SHELL) FOR THE EXTERNAL BEND RELIEF.

    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