BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P240029 · Decision Jun 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    CGuard Prime Carotid Stent System
    PMA Number
    P240029
    Device Class
    FDA Class 3
    Product Code
    NIM
    Generic Name
    Stent, carotid
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 23, 2025
    Date Received
    September 16, 2024
    Expedited Review
    N

    Advisory Committee Statement

    The CGuard Prime Carotid Stent System, when used in conjunction with embolic protection devices specified in the labeling, is indicated for improving carotid luminal diameter in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet both criteria outlined below:• Patients with neurological symptoms and >=50% stenosis of the common or internal carotid artery by angiogram or patients without neurological symptoms and >=80% stenosis of the common or internal carotid artery by angiogram.• Patients having a vessel with reference diameters between 6.4mm and 9.0 mm at the target lesion.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid