BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P040012 · Supplement: S031 · Decision Apr 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    RX ACCULINK CAROTID STENT SYSTEM
    PMA Number
    P040012
    Supplement Number
    S031
    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
    April 30, 2010
    Date Received
    November 2, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE INDICATION STATEMENT AND INSTRUCTIONS FOR USE TO INCORPORATE USE WITH THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM. THE DEVICE, AS MODIFIED, WILLBE MARKETED UNDER THE TRADE NAME RX ACCULINK CAROTID STEM SYSTEM AND IS INDICATED FOR USEIN CONJUNCTION WITH ABBOTT VASCULAR'S ACCUNET OR EMBOSHIELD FAMILY OF EMBOLIC PROTECTIONSYSTEMS, FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA AS PREVIOUSLY APPROVED.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid