BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P050019 · Supplement: S004 · Decision Jul 28, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    BOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
    PMA Number
    P050019
    Supplement Number
    S004
    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
    July 28, 2010
    Date Received
    February 1, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REPLACING THE PARTIALLY ENCAPSULATED RADIOPAQUE MARKERBAND ON THE DISTAL END OF THE RETRACTABLE OUTER SHEATH IN THE STENT DELIVERY SYSTEM WITH A FULLY ENCAPSULATED RADIOPAQUE MARKERBAND.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid