BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P020006 · Supplement: S008 · Decision Jun 2, 2005
    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
    Supplement Number
    S008
    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
    Decision Code
    APPR
    Decision Date
    June 2, 2005
    Date Received
    January 10, 2005
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION, WAYNE, NEW JERSEY TO CONDUCT PACKAGING AND LABELING OPERATIONS.

    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