BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Stent

    PMA: P150028 · Supplement: S003 · Decision Jul 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Aortic Stent
    Trade Name
    Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
    PMA Number
    P150028
    Supplement Number
    S003
    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
    July 20, 2018
    Date Received
    June 27, 2018
    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 quality control inspection step to the Mounted CP Stent manufacturing process.

    Classifications

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

    Product Code Device Name
    PNF Aortic Stent