BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P990046 · Decision Oct 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    ATS OPEN PIVOT BILEAFLET HEART VALVE
    PMA Number
    P990046
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 13, 2000
    Date Received
    July 29, 1999
    Expedited Review
    N
    Docket Number
    00M-1570

    Advisory Committee Statement

    APPROVAL FOR THE ATS OPEN PIVOT BILEAFLET HEART VALVE, STANDARD AORTIC MODEL A500FA 21, 23, 25, 27, AND 29 MM, STANDARD MITROAL MODEL 500DM 29, 31, AND 33 MM, ADVANCED PERFORMANCE (AP) AORTIC MODEL 501DA 18, 20, 22, 24, AND 26 MM, AND AP MITRAL MODEL 510DM 26 AND 28 MM. THE DEVICE IN INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL VALVES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWQ Heart-Valve, Mechanical