BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P060038 · Supplement: S026 · Decision Jan 13, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    Crown PRT Aortic Pericardial Heart Valve with PR Treatment
    PMA Number
    P060038
    Supplement Number
    S026
    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
    January 13, 2016
    Date Received
    November 4, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL DL, NAMELY THE ADDITION OF RADIOGRAPHIC MARKERS ON THE SEWING RING AND ADDITION OF VISIBLE MARKERS ON THE SEWING CUFF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CROWN PRT AORTIC PERICARDIAL HEART VALVE WITH PR TREATMENT 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