BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P830039 · Supplement: S007 · Decision Jul 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    OMNICARBON CARDIAC VALVE PROSTHESIS
    PMA Number
    P830039
    Supplement Number
    S007
    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
    July 26, 2001
    Date Received
    October 24, 1996
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    01M-0380

    Advisory Committee Statement

    APPROVAL FOR THE OMNICARBON(TM) CARDIAC VALVE PROSTHESIS, AORTIC MODEL 3313 IN SIZES 23, 25, 27, AND 29 MM, AND MITRAL SUPRA-ANNULAR MODEL 3523 IN SIES 27, 29, 31, AND 33 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF DYSFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL HEART VALVES.

    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