BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P000029 · Supplement: S002 · Decision Dec 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    DEFLUX INJECTABLE GEL
    PMA Number
    P000029
    Supplement Number
    S002
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 18, 2002
    Date Received
    November 22, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN SITE FOR BACTERIAL ENDOTOXIN TESTING FOR THE DEFLUX NEEDLE, A COMPONENT OF THE DEFLUX DEVICE. THE TESTING IS CURRENTLY CONDUCTED AT A CONTRACT FACILITY, NAMSA, AND WILL BE MOVED TO Q-MED'S MICROBIOLOGY QC LABORATORY IN UPPSALA, SWEDEN. THERE WILL ALSO BE A CHANGE OF TEST METHOD FROM KINETIC-CHROMOGENIC LAL PROCEDURE TO THE GEL CLOT LAL TEST.

    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