BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    PMA: P990040 · Supplement: S030 · Decision Feb 28, 2023
    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
    PMA Number
    P990040
    Supplement Number
    S030
    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
    February 28, 2023
    Date Received
    November 17, 2022
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for new manufacturing sites located at: 1) Steris Isomedix Services, 1175 Isuzu Parkway, Grand Prairie, Texas, 75050; 2) Steris Isomedix Services, 7685 St. Andrews Avenue, San Diego, California, 92154; and 3) Sterigenics, 2400 Airport Road, Santa Teresa, New Mexico, 88008. These manufacturing sites will be performing sterilization of the TRUFILL n-BCA Liquid Embolic System.

    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