BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Stent

    PMA: P240003 · Supplement: S003 · Decision Mar 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Aortic Stent
    Trade Name
    Minima Stent System
    PMA Number
    P240003
    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
    March 11, 2025
    Date Received
    February 10, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for quality controls in the manufacturing process that add a minimum fillet size specification and a maximum length specification to provide additional assurance of strength and reliability of the Minima 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