BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P060025 · Supplement: S010 · Decision May 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    3F AORTIC BIOPROSTHESIS
    PMA Number
    P060025
    Supplement Number
    S010
    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
    May 29, 2013
    Date Received
    February 22, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE RINSING AND FIXATIONS SOLUTIONS USED INTHE MANUFACTURE OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 3F AORTIC BIOPROSTHESIS, MODEL 1000 AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.

    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