BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P170008 · Decision Nov 28, 2017
    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
    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 28, 2017
    Date Received
    March 13, 2017
    Expedited Review
    N
    Docket Number
    17M-6650

    Advisory Committee Statement

    Approval for the EluNIR Ridaforolimus Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo lesions <=30mm 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