BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Adhesive Internal Use

    PMA: P220024 · Supplement: S005 · Decision Jan 14, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Tissue Adhesive Internal Use
    Trade Name
    LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
    PMA Number
    P220024
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    PLJ
    Generic Name
    Tissue adhesive internal use
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 14, 2026
    Date Received
    October 21, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    approval of the revised protocol to enhance enrollment of the LIQUFIX Post-Approval Study (PAS). The changes are, namely, revising the enrollment milestone dates. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220024.

    Classifications

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

    Product Code Device Name
    PLJ Tissue Adhesive Internal Use