BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P970031 · Decision Nov 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
    PMA Number
    P970031
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 26, 1997
    Date Received
    July 14, 1997
    Expedited Review
    N
    Docket Number
    98M-0906

    Advisory Committee Statement

    Approval for the Medtronic FREESTYLE(R) Aortic Root Bioprosthesis, Model 995; sizes 19, 21, 23, 25, 27 mm; implantation techniqures, subcoronary, full-root, and root inclusion; and the FREESTYLE(R) Aortic Obturators, Model 7990 and the Medtronic Handle, Model 0791. This device is a replacement heart valve and is indicated for the replacement of malfunctioning native or prosthetic aortic valves with the optio of aortic root replacement.

    Classifications

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

    Product Code Device Name
    LWR Heart-Valve, Non-Allograft Tissue