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

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P980053 · Supplement: S001 · Decision Nov 1, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    DURASPHERE INJECTABLE BULKING AGENT
    PMA Number
    P980053
    Supplement Number
    S001
    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
    November 1, 2000
    Date Received
    October 6, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF AN ALTERNATE SUBCONTRACTOR TO HEAT-SEAL THE TRAY LID PACKAGE FOR THE DURASPHERE INJECTABLE BULKING AGENT(R) AND AN ALTERNATE SUPPLIER FOR TYVEC 1078B LID FOR USE BY THE ALTERNATE SUBCONTRACTOR.

    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