BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P100047 · Supplement: S022 · Decision Jul 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
    PMA Number
    P100047
    Supplement Number
    S022
    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
    July 3, 2013
    Date Received
    May 31, 2013
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OF THE DEVICE TO INCLUDE WARNINGS AND INFORMATION RELATED TO ELECTROSTATIC DISCHARGE EXPOSURE AND EXCHANGING POWER SOURCES.

    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