BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P030047 · Decision Sep 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    CORDIS PRECISE NITINOL STENT SYSTEM
    PMA Number
    P030047
    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
    September 22, 2006
    Date Received
    October 8, 2003
    Expedited Review
    Y
    Docket Number
    06M-0412

    Advisory Committee Statement

    APPROVAL FOR THE CORDIS PRECISE NITINOL STENT SYSTEM (5.5 FR AND 6.0 FR SIZES, OVER-THE-WIRE CONFIGURATION). THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH THE ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY (DEFINED IN THE IFU) WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >=50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM, AND 2) PATIENTS MUST HAVE A VESSEL DIAMETER OF 4-9MM AT THE TARGET LESION. THE VESSEL DISTAL TO THE TARGET LESION MUST BE WITHIN THE RANGE OF 3MM AND 7.5MM TO ALLOW FOR PLACEMENT OF THE ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid