BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P170008 · Supplement: S019 · Decision Nov 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    EluNIR Ridaforolimus Eluting Coronary Stent System
    PMA Number
    P170008
    Supplement Number
    S019
    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
    November 19, 2019
    Date Received
    July 10, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the expansion of the EluNIR Ridaforolimus Eluting Coronary Stent System product matrix by adding stent length of 38 mm in diameters 2.75, 3.0, 3.5 and 4.0 mm. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo lesions <=36mm in length in native coronary arteries with reference diameter of 2.50mm to 4.25mm.

    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