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

    Stent, Carotid

    PMA: P030047 · Supplement: S008 · Decision Nov 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    PRECISE NITINOL STENT SYSTEM & PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM
    PMA Number
    P030047
    Supplement Number
    S008
    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
    November 30, 2007
    Date Received
    November 2, 2007
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE BIOLOGICAL INDICATORS USED TO MONITOR THE ETHYLENE OXIDE STERILIZATION CYCLES (USE OF A SELF CONTAINED BIOLOGICAL INDICATOR IN PLACE OF A SPORE STRIP BIOLOGICAL INDICATOR).

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid