BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P050025 · Supplement: S007 · Decision Dec 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM
    PMA Number
    P050025
    Supplement Number
    S007
    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
    December 20, 2007
    Date Received
    December 7, 2007
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LABELING CLARIFICATION FOR ?ARRYTHMIA?, THE ADDITION OF ?STENT FRACTURE? TO THE LIST OF POTENTIAL ADVERSE EVENTS, AND CLARIFICATIONS TO THE LABELING TO CLARIFY COMPLETE REMOVAL OF THE DELIVERY SYSTEM TRACKING TIP FROM GUIDE HEATH OR GUIDE CATHETER WHEN REMOVING THE DEVICE UNDER FLUOROSCOPY (ITEMS 11, 12, AND 17 OR TABLE 1).

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid