BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Anti-Gastroesophageal Reflux

    PMA: P100049 · Supplement: S033 · Decision Oct 4, 2022
    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
    S033
    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 4, 2022
    Date Received
    April 8, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following labeling updates: 1) inclusion of final post-approval study results; 2) addition of a precaution based on RELIEF study results; 3) addition of “swallow-induced syncope to the list of adverse events; and 4) revised registered/trademark status.

    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