BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Percutaneously Delivered Prostheses And Tricuspid Valves

    PMA: P230013 · Supplement: S004 · Decision Oct 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Percutaneously Delivered Prostheses And Tricuspid Valves
    Trade Name
    Edwards EVOQUE Tricuspid Valve Replacement System
    PMA Number
    P230013
    Supplement Number
    S004
    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
    October 3, 2024
    Date Received
    April 25, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for (1) addition of the 56 mm valve size; (2) various minor material and manufacturing changes to all valve sizes, including changing the anchor padding material and laser-cutting of the cloth components; and (3) various design changes to the EVOQUE loading system (Model 9850LSA).

    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