BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Stent

    PMA: P150028 · Supplement: S006 · Decision Dec 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Aortic Stent
    Trade Name
    G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent
    PMA Number
    P150028
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    PNF
    Generic Name
    Aortic stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 13, 2021
    Date Received
    September 14, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the G-Armor Stent Family and includes dimensional design modifications to the currently approved CP Stent Family.

    Classifications

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

    Product Code Device Name
    PNF Aortic Stent