BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P150011 · Supplement: S030 · Decision Jan 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    Perceval Sutureless Heart Valve, Perceval PLUS Sutureless Heart Valve
    PMA Number
    P150011
    Supplement Number
    S030
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 24, 2025
    Date Received
    October 31, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for design changes related to the sutures and collar of the Perceval PLUS Sutureless Heart Valve, as well as manufacturing process changes. Manufacturing changes include the introduction of an automated laser cut process, introduction of a zero-pressure shaping process, and a change in the supplier of several suture threads.

    Classifications

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

    Product Code Device Name
    LWR Heart-Valve, Non-Allograft Tissue