BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P070015 · Supplement: S134 · Decision Feb 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    XIENCE V Everolimus Eluting Coronary Stent System; XIENCE nano EECSS
    PMA Number
    P070015
    Supplement Number
    S134
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 21, 2017
    Date Received
    September 12, 2016
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the use of an alternate test method, Fourier Transform Near Infra-Red Spectroscopy (FT-NIR), for the testing of in-process drug coating solution. This method will be used as an alternate to the current High Performance Liquid Chromatography (HPLC) methods.

    Classifications

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

    Product Code Device Name
    NIQ Coronary Drug-Eluting Stent