BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Percutaneously Delivered Prostheses And Tricuspid Valves

    PMA: P230013 · Supplement: S001 · Decision Mar 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Percutaneously Delivered Prostheses And Tricuspid Valves
    Trade Name
    EVOQUE Transcatheter Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System
    PMA Number
    P230013
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    NPW
    Generic Name
    Percutaneously Delivered Prostheses and Tricuspid Valves
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 15, 2024
    Date Received
    February 26, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at 12050 Lone Peak Parkway, Draper, UT 84020 as an alternative finished goods manufacturing site for the EVOQUE transcatheter tricuspid delivery system, EVOQUE dilator kit, and EVOQUE loading System

    Classifications

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

    Product Code Device Name
    NPW Percutaneously Delivered Prostheses And Tricuspid Valves