BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P040012 · Supplement: S042 · Decision Mar 29, 2012
    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
    S042
    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
    March 29, 2012
    Date Received
    September 19, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITION OF THE EMBOSHIELD FAMILY OF EMBOLIC PROTECTION SYSTEMS (EPS) TO THE STANDARD RISK INDICATION AND AN UPDATE TO THE MAGNETIC RESONANCE COMPATIBILITY SECTION OF THE LABELING.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid