BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implant, Anti-Gastroesophageal Reflux

    PMA: P100049 · Supplement: S007 · Decision Dec 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Implant, Anti-Gastroesophageal Reflux
    Trade Name
    LINX REFLUX MANAGEMENT SYSTEM
    PMA Number
    P100049
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    LEI
    Generic Name
    IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 27, 2013
    Date Received
    December 4, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE FIRMS CLEANING MACHINE, CLEANING DETERGENT, MAXIMUM BEAD LOAD AND CLEANING TEMPERATURE, AND THE ADDITION OF MESHES DURING THE CLEANING AND RINSING PROCESS.

    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