BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Anti-Gastroesophageal Reflux

    PMA: P100049 · Supplement: S010 · Decision Jul 22, 2014
    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
    S010
    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
    July 22, 2014
    Date Received
    June 23, 2014
    Supplement Type
    Special (Immediate Track)
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING ALTERATIONS INCLUDING ADVERSE EVENT INFORMATION ABOUT EROSION OF THE LINX DEVICE, CLARIFICATIONS OR CONTRAINDICATIONS REGARDING NICKEL, WARNINGS REGARDING STORAGE AND USE ABOVE 60 DEGREES C, ADDITIONAL POTENTIAL RISK OF SALIVA/MUCUS BUILD-UP, AND DIRECTIONS WHICH ADD THE REMOVAL OF SUTURES AFTER THE CLASP ENDS ARE FULLY ENGAGED.

    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