BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P150048 · Supplement: S060 · Decision Dec 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
    PMA Number
    P150048
    Supplement Number
    S060
    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
    December 29, 2022
    Date Received
    February 4, 2022
    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 a manufacturing site located at 35 Changi North Crescent, Changi, Singapore, 499641 for RESILIA/GLX processing and final packaging of the INSPIRIS RESILIA Aortic Valves, as well as an alternate ethylene oxide sterilization site at Sterile Services Singapore, 47 Jaran Buroh Unit #01-01, Singapore South West, Singapore 619491.

    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