BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P150036 · Decision Aug 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    EDWARDS INTUITY ELITE VALVE SYSTEM
    PMA Number
    P150036
    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
    August 12, 2016
    Date Received
    October 13, 2015
    Expedited Review
    N
    Docket Number
    16M-2485

    Advisory Committee Statement

    Approval for the EDWARDS INTUITY Elite Valve System. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

    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