BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P060038 · Supplement: S002 · Decision Feb 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX
    PMA Number
    P060038
    Supplement Number
    S002
    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 27, 2009
    Date Received
    December 29, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MANUFACTURING PROCESS IMPROVEMENTS TO THE AORTIC PERICARDIAL HEART VALVE MODEL 12. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDE THE TRADE NAME MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX 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