BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P040021 · Supplement: S004 · Decision Nov 15, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    SJM EPIC VALVE AND SJM EPIC SUPRA VALVE
    PMA Number
    P040021
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    DYE
    Generic Name
    replacement Heart-valve
    Regulation Number
    870.3925
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 15, 2007
    Date Received
    September 29, 2006
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    08M-0084

    Advisory Committee Statement

    APPROVAL FOR THE EPIC VALVE IN AORTIC SIZES 21, 23, 25, 27 AND 29 MM, AND IN MITRAL SIZES 27, 29, 31 AND 33 MM, AND THE SJM EPIC SUPRA VALVE IN AORTIC VALVE SIZES 19, 21, 23, 25 AND 27 MM. THE DEVICE IS INDICATED FOR PATIENTS REQUIRING REPLACEMENT OF A DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE AORTIC AND/OR MITRAL HEART VALVE. IT MAY ALSO BE USED AS A REPLACEMENT FOR A PREVIOUSLY IMPLANTED AORTIC AND/OR MITRAL PROSTHETIC HEART VALVE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DYE Replacement Heart-Valve