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: S035 · Decision May 28, 2025
    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-BCA Liquid Embolic System (LES) and Procedural Set
    PMA Number
    P990040
    Supplement Number
    S035
    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
    May 28, 2025
    Date Received
    May 5, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for the temporary relocation of equipment and manufacturing operations from one cleanroom (ISO Class 8) to another cleanroom (ISO Class 8) within the same building

    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