BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Anti-Gastroesophageal Reflux

    PMA: P790006 · Supplement: S001 · Decision Sep 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Implant, Anti-Gastroesophageal Reflux
    Trade Name
    ANTI-REFLUX PROSTHESIS
    PMA Number
    P790006
    Supplement Number
    S001
    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
    September 10, 1980
    Date Received
    January 10, 1980
    Expedited Review
    N

    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