BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P000037 · Decision May 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
    PMA Number
    P000037
    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
    May 30, 2001
    Date Received
    September 1, 2000
    Expedited Review
    N
    Docket Number
    01M-0270

    Advisory Committee Statement

    APPROVAL FOR THE ON-X. PROSTHETIC HEART VALVE, MODEL ONXA IN THE AORTIC POSITION INCLUDING SIZES 19, 21, 23, 25, AND 27/29 MM. THIS DEVICE IS INDICATED FOR REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVES IN THE AORTIC POSITION.

    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