BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glue, Surgical, Arteries

    PMA: P010003 · Supplement: S042 · Decision Mar 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Glue, Surgical, Arteries
    Trade Name
    BioGlue® Surgical Adhesive
    PMA Number
    P010003
    Supplement Number
    S042
    Device Class
    FDA Class 3
    Product Code
    MUQ
    Generic Name
    Glue, surgical, arteries
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 18, 2025
    Date Received
    December 18, 2023
    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 the addition of:• STERIS, located at 1800 Industrial Drive, Libertyville, IL 60048, FEI #1450662, as an alternate sterilization site for the BioGlue Surgical Adhesive syringes• Medline Industries – Northpoint Services, located at 1160 S. Northpoint Blvd, Waukegan, IL 60085, FEI #1000514656, as an alternate sterilization site the Syringe Extender Tips accessory

    Classifications

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

    Product Code Device Name
    MUQ Glue, Surgical, Arteries