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

    Tricuspid Valve Repair Device, Percutaneously Delivered

    PMA: P230007 · Supplement: S016 · Decision Aug 18, 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 Delivery System
    PMA Number
    P230007
    Supplement Number
    S016
    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
    August 18, 2025
    Date Received
    July 21, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to change the incoming inspection sampling plan for components of the TriClip and MitraClip Delivery Systems from an Attribute Acceptable Quality Limit (AQL) to a variable-based plan with custom sampling plan requirements

    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