BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P000037 · Supplement: S018 · Decision Jan 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    ON-X ASCENDING AORTIC PROSTHESIS
    PMA Number
    P000037
    Supplement Number
    S018
    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
    January 14, 2011
    Date Received
    January 4, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT VASCUTEK, LTD., SCOTLAND, GREAT BRITAIN (UK). ALSO APPROVAL FOR A VALVED CONDUIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER HE TRADE NAME ON-X ASCENDING AORTIC PROSTHESIS AND IS INDICATED FOR THE REPLACEMENT OF A DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVE IN THE AORTIC POSITION IN CASES THAT INVOLVE AN ASCENDING AORTIC ANEURYSM OR OTHER ASSOCIATED AORTIC DISEASE.

    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