BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P900060 · Supplement: S041 · Decision Dec 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    CARBOMEDICS PROSTHETIC HEART VALVE
    PMA Number
    P900060
    Supplement Number
    S041
    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
    December 21, 2011
    Date Received
    February 28, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXTEND THE MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY FROM 1.5 TESLA TO 3.0 TESLA AND TO INCORPORATE OTHER LABELING REVISIONS FOR THE PURPOSE OF UNIFYING AND REBRANDING THE US MARKET LABELS WITH OTHER, NON-US MARKET LABELS.

    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