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

    Tricuspid Valve Repair Device, Percutaneously Delivered

    PMA: P230007 · Supplement: S018 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Tricuspid Valve Repair Device, Percutaneously Delivered
    Trade Name
    TriClip G4 System
    PMA Number
    P230007
    Supplement Number
    S018
    Device Class
    FDA Class 3
    Product Code
    NPS
    Generic Name
    Tricuspid valve repair device, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 17, 2025
    Date Received
    September 19, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the substitution of commercially available DC shaft components used for process monitoring with vendor inspected DC shaft components with specific reject reasons that do not impact bond integrity, and a change in the incoming sampling plan of 8 components from 100% inspection to RQL

    Classifications

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

    Product Code Device Name
    NPS Tricuspid Valve Repair Device, Percutaneously Delivered