BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S088 · Decision Dec 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    REGENT, STANDARD AND MASTERS MECHANICAL HEART VALVE
    PMA Number
    P810002
    Supplement Number
    S088
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 19, 2013
    Date Received
    December 3, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF A NEW SEALING PLATE CONFIGURATION AND A CHANGE IN SEALING PARAMETERS FOR THE TYVEK LID OF THE INNER AND OUTER TRAYS FOR MECHANICAL HEART VALVE PACKAGING AT ONE MANUFACTURING FACILITY.

    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