BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P190023 · Supplement: S030 · Decision Apr 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    Navitor Transcatheter Aortic Valve Implantation System
    PMA Number
    P190023
    Supplement Number
    S030
    Device Class
    FDA Class 3
    Product Code
    NPT
    Generic Name
    Aortic valve, prosthesis, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 15, 2026
    Date Received
    January 15, 2026
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for design, supplier, material, and manufacturing process changes to the FlexNav™ Delivery System

    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