BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P150048 · Supplement: S079 · Decision Mar 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    MITRIS RESILIA Mitral Valve
    PMA Number
    P150048
    Supplement Number
    S079
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 1, 2024
    Date Received
    February 6, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for adding Edwards Singapore located at 35 Changi North Crescent, Changi, Singapore, 499641 as a MITRIS RESILIA Mitral Valve manufacturing site and adding Sterile Services Singapore, 47 Jaran Buroh Unit #01-01, Singapore South West, Singapore 619491 as a MITRIS RESILIA Mitral Valve sterilization site.

    Classifications

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

    Product Code Device Name
    LWR Heart-Valve, Non-Allograft Tissue