BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P830039 · Supplement: S011 · Decision Oct 29, 2002
    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
    S011
    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
    October 29, 2002
    Date Received
    May 7, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE OMNICARBON CARDIAC VALVE PROSTHESIS IN THE ADDITIONAL SIZE OF 21 MM OF THE MODEL 3313 (AORTIC) AND SIZE 25 MM OF THE MODEL 3523 (MITRAL). THE SUPPLEMENT REQUESTED APPROVAL OF THESE SIZES AS AN ADDITION TO THE EXISTING, APPROVED (JULY 26, 2001; P830039/S007) PRODUCT LINE OF AORTIC SIZES 23, 25, 27 AND 29 MM, AND MITRAL SIZES 27, 29, 31, AND 33 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC AND MITRAL 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