BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Stent

    PMA: P150028 · Supplement: S001 · Decision Oct 24, 2017
    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
    S001
    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
    October 24, 2017
    Date Received
    February 17, 2017
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    17M-6290

    Advisory Committee Statement

    Approval for the Covered CP Stent and Covered Mounted CP Stent Models. This device is indicated for use in the treatment of right ventricle to pulmonary artery (right ventricular outflow tract, RVOT) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement (TPVR). In addition, approval for additional sizes (10-zig and lengths up to 60 mm for 8- and 10-zig configurations) for the Cheatham Platinum Stent System.

    Classifications

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

    Product Code Device Name
    PNF Aortic Stent