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

    Stent, Carotid

    PMA: P050025 · Supplement: S006 · Decision Aug 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    NEXSTENT CAROTID STENT AND MONORAIL DELIVERY SYSTEM
    PMA Number
    P050025
    Supplement Number
    S006
    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
    August 24, 2007
    Date Received
    July 26, 2007
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF A 100% INSPECTION TEST TO BE IMPLEMENTED IN RECEIVING INSPECTION AND A 100% IN-PROCESS VISUAL VERIFICATION TO ENSURE THAT CONNECTOR BLOCKS PROPERLY TRANSMIT UV LIGHT.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid