BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P060001 · Supplement: S020 · Decision Jan 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    PROTEGE GPS SELF EXPANDING PERIPHERAL STENT SYSTEM
    PMA Number
    P060001
    Supplement Number
    S020
    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
    January 21, 2015
    Date Received
    May 2, 2014
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    15M-0228

    Advisory Committee Statement

    APPROVAL FOR THE PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO AND INCLUDING 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF7.5 TO 11 MM.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid