BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Anti-Gastroesophageal Reflux

    PMA: P100049 · Supplement: S038 · Decision Oct 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Implant, Anti-Gastroesophageal Reflux
    Trade Name
    LINX Reflux Management System
    PMA Number
    P100049
    Supplement Number
    S038
    Device Class
    FDA Class 3
    Product Code
    LEI
    Generic Name
    IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 8, 2025
    Date Received
    December 20, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    for the manufacturing site change.

    Classifications

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

    Product Code Device Name
    LEI Implant, Anti-Gastroesophageal Reflux