BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stent, Carotid

    PMA: P050019 · Supplement: S007 · Decision May 2, 2011
    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 (CAROTID WALLSTENT ENDOPROSTHESIS)
    PMA Number
    P050019
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    NIM
    Generic Name
    Stent, carotid
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 2, 2011
    Date Received
    April 1, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    SEVERAL EQUIPMENT UPGRADES, A CHANGE TO THE PHYSICAL LINE LAYOUT, AND INTRODUCTION OF AUTOMATED PROCESS SETTINGS.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid