BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P000037 · Supplement: S028 · Decision Feb 13, 2013
    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
    S028
    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
    February 13, 2013
    Date Received
    June 28, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFIED AORTIC SEWING CUFF AS AN EXTENSION TO THE LINE OF AVAILABLE VALVES; THE REQUEST APPLIED TO THE AORTIC SIZES OF 19, 21, 23, 25, AND 27/29 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ON-X AORTIC PROSTHETIC HEART VALVE WITH ANATOMIC SEWING RING, AND WILL BE GIVEN THE MODEL DESIGNATIONS OF ONXAN (STANDARD VALVE HOLDER) AND ONXANE (EXTENDED VALVE HOLDER).

    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