BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P190023 · Supplement: S028 · Decision Oct 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    FlexNav Delivery System; Navitor Transcatheter Aortic Valves
    PMA Number
    P190023
    Supplement Number
    S028
    Device Class
    FDA Class 3
    Product Code
    NPT
    Generic Name
    Aortic valve, prosthesis, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 15, 2025
    Date Received
    September 18, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change to the endotoxin extraction sample preparation method and to add the PyroGene endotoxin test method to detect bacterial endotoxins

    Classifications

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

    Product Code Device Name
    NPT Aortic Valve, Prosthesis, Percutaneously Delivered