BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P060001 · Supplement: S008 · Decision Apr 28, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM
    PMA Number
    P060001
    Supplement Number
    S008
    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
    April 28, 2010
    Date Received
    March 29, 2010
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A NEW MATERIAL SPECIFICATION AND AN INCOMING INSPECTION STEP FOR THE ANNEALED TANTALUM SPHERE COMPONENTS OF THE DEVICE.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid