BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P210014 · Decision Dec 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex
    PMA Number
    P210014
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 13, 2021
    Date Received
    April 1, 2021
    Expedited Review
    N
    Docket Number
    21M-1321

    Advisory Committee Statement

    Approval for the SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System. The device is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions <= 24 mm in length in native coronary arteries with >= 2.25 mm to <= 4.00 mm reference vessel diameters, using direct stenting or pre-dilatation interventional techniques. DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions <= 34 mm in length in native coronary arteries with >= 2.25 mm to <= 4.00 mm reference vessel diameters, using direct stenting or pre-dilatation interventional techniques.

    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