BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S121 · Decision Apr 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology
    PMA Number
    P810002
    Supplement Number
    S121
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 3, 2024
    Date Received
    January 23, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    for implementing rebranding of the SJM Masters Series Mechanical Heart Valve, SJM Regent Mechanical Heart Valve, and SJM Masters Valved Graft with Hemashield graft technology.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWQ Heart-Valve, Mechanical