BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P000037 · Supplement: S001 · Decision Mar 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    ON-X PROSTHETIC HEART VALVE
    PMA Number
    P000037
    Supplement Number
    S001
    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
    March 6, 2002
    Date Received
    September 7, 2001
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    02M-0255

    Advisory Committee Statement

    APPROVAL FOR THE ON-X PROSTHETIC HEART VALVE, MODEL ONXM IN SIZES 25 MM, 27/29 MM, 31/33 MM, AND MODEL ONXMC IN SIZE 25/33 MM IN THE MITRAL POSITION. THIS DEVICE IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVES IN THE MITRAL 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