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

    Tricuspid Valve Repair Device, Percutaneously Delivered

    PMA: P230007 · Supplement: S012 · Decision May 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Tricuspid Valve Repair Device, Percutaneously Delivered
    Trade Name
    TriClip G4 Delivery System;TriClip G5 Delivery System
    PMA Number
    P230007
    Supplement Number
    S012
    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
    May 18, 2025
    Date Received
    April 28, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change in the incoming inspection requirement for functional inspection points for a subassembly component used in the manufacture of the MitraClip and TriClip clip delivery systems (CDS)

    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