BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P900060 · Supplement: S018 · Decision Mar 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    SULZER CARBOMEDICS ORBIS PROSTHETIC HEART VALVE
    PMA Number
    P900060
    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
    March 17, 1999
    Date Received
    September 18, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a sewing cuff modification of the CarboMedics(R) Prosthetic Heart Valve. The device, as modified, will be marketed under the trade name Sulzer Carbomedics Orbis(TM) Prosthetic Heart Valve and will be available in the following model numbers and sizes: Model 100 (aortic sizes 19, 21, 23, 25, 27, 29, and 31mm), and Model 200 (mitral sizes 21, 23, 25, 27, 29, 31, and 33mm).

    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