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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Carotid

    PMA: P180010 · Decision Nov 1, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    Gore Carotid Stent
    PMA Number
    P180010
    Device Class
    FDA Class 3
    Product Code
    NIM
    Generic Name
    Stent, carotid
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 1, 2018
    Date Received
    March 23, 2018
    Expedited Review
    N
    Docket Number
    18M-4205

    Advisory Committee Statement

    Approval for the GORE® Carotid Stent, used with the GORE® Embolic Filter. The device is indicated for the treatment of carotid artery stenosis in patients deemed at high surgical risk for carotid endarterectomy (CEA) and who meet the criteria below.1) Patients with symptomatic carotid artery stenosis, >= 50%, as confirmed by ultrasound or angiography;2) Patients with asymptomatic carotid artery stenosis, >=80%, as confirmed by ultrasound or angiography; and 3) Patients must have a Reference Vessel Diameter of 3.7 mm to 9.0 mm.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid