BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    PMA: P990040 · Supplement: S001 · Decision May 30, 2001
    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(R) N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
    PMA Number
    P990040
    Supplement Number
    S001
    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
    Approved
    Decision Code
    APPR
    Decision Date
    May 30, 2001
    Date Received
    March 1, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REMOVAL OF THE POST ETHYLENE OXIDE STERILIZATION PYROGEN TEST OF THE N-BCA, REMOVAL OF THE POST-STERILIZATION FUNCTIONAL TESTING OF THE TANTALUM POWDER, THE ADDITION OF A PYROGEN TEST OF THE TANTALUM POWDER, AND THE VALIDATION OF THE PYROGENICITY TEST.

    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