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

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    PMA: P990040 · Supplement: S007 · Decision Feb 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
    Trade Name
    TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
    PMA Number
    P990040
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    KGG
    Generic Name
    tissue adhesive for use in embolization of brain arteriovenous malformations
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 6, 2009
    Date Received
    December 19, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES AND MODIFICATIONS AS FOLLOWS: 1) THE TRANSFER OF THE MANUFACTURING OF THE TRUFILL N-BCA LIQUID EMBOLIC SYSTEM FROMONE BUILDING TO ANOTHER WITHIN THE SAME FACILITY;2) A CLARIFICATION OF THE INSTRUCTIONS FOR USE (1FU)THE REMOVAL OF A REDUNDANT INCOMING RECEIVING INSPECTION FOR THE N-BCA AND TANTALUMPOUCH;3) THE REMOVAL OF A SPECIFICATION FOR THE N-BCA AND TANTALUM POUCH; AND4) MODIFICATION OF THE SEAL SPECIFICATIONS FOR THE N-BCA AND TANTALUM POUCH.

    Classifications

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

    Product Code Device Name
    KGG Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations