BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Anti-Gastroesophageal Reflux

    PMA: P100049 · Supplement: S006 · Decision Dec 19, 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
    S006
    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
    December 19, 2013
    Date Received
    May 7, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN UPDATE TO THE LABELING FOR THE LINX DEVICE REGARDING EXPOSURE TO MRI SCANS.

    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