BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tricuspid Valve Repair Device, Percutaneously Delivered

    PMA: P230007 · Supplement: S002 · Decision Jun 20, 2024
    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
    PMA Number
    P230007
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    NPS
    Generic Name
    Tricuspid valve repair device, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 20, 2024
    Date Received
    April 22, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    alternate model numbers under the existing trade name for the MitraClip G4 System, and alternate trade name and model numbers for the TriClip G4 System

    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