BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S078 · Decision Nov 1, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    ST. JUDE MEDICAL MECHANICAL HEART VALVE
    PMA Number
    P810002
    Supplement Number
    S078
    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
    November 1, 2012
    Date Received
    August 17, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE (IFU), ST. JUDE MEDICAL (SJM) INTERNET, AND ANY OTHER APPLICABLE DEVICE LABELING TO INCLUDE THE NEW MAGNETIC RESONANCE IMAGING (MRI) TESTING INFORMATION TO ENHANCE THE SAFE USE OF THE DEVICE WHEN UNDERGOING MRI.

    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