BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P060038 · Decision Oct 23, 2007
    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
    PMA Number
    P060038
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    October 23, 2007
    Date Received
    December 18, 2006
    Expedited Review
    N
    Docket Number
    07M-0410

    Advisory Committee Statement

    APPROVAL FOR THE MITROFLOW AORTIC PERICARDIAL HEART VALVE, SIZES 19, 21, 23, 25, AND 27 MM. THE DEVICE IS INTENDED 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