BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P020006 · Decision Apr 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    ENTERYX PROCEDURE KIT
    PMA Number
    P020006
    Device Class
    FDA Class 3
    Product Code
    LNM
    Generic Name
    AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    April 22, 2003
    Date Received
    February 11, 2002
    Expedited Review
    N
    Docket Number
    04M-0145

    Advisory Committee Statement

    APPROVAL FOR THE ENTERYX PROCEDURE KIT. THE DEVICE IS INDICATED FOR ENDOSCOPIC INJECTION INTO THE REGION OF THE LOWER ESOPHAGEAL SPHINCTER (LES) FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD) SYMPTOMS IN PATIENTS RESPONDING TO AND REQUIRING DAILY PHARMACOLOGICAL THERAPY WITH PROTON PUMP INHIBITORS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNM Agent, Bulking, Injectable For Gastro-Urology Use