BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    PMA: P990040 · Decision Sep 25, 2000
    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 LIQUID EMBOLIC SYSTEM
    PMA Number
    P990040
    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
    September 25, 2000
    Date Received
    July 16, 1999
    Expedited Review
    N
    Docket Number
    00M-1569

    Advisory Committee Statement

    APPROVAL FOR THE TRUFILL(R) N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM. THE DEVICE IS INDICATED FOR THE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WHEN PRESURGICAL DEVASCULARIZATION IS DESIRED.

    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