BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P990064 · Supplement: S053 · Decision Feb 5, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    MOSIAC PORCINE BIOPROSTHESIS
    PMA Number
    P990064
    Supplement Number
    S053
    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
    February 5, 2014
    Date Received
    January 9, 2014
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INCLUSION OF AN INDEXED EFFECTIVE ORIFICE AREA (IEOA) SIZING CHART IN THE IFU AND AN UPDATE TO THE SIZERS TO ALIGN WITH THE UPDATED IEOA SIZING CHART.

    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