BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glue, Surgical, Arteries

    PMA: P010003 · Supplement: S003 · Decision May 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Glue, Surgical, Arteries
    Trade Name
    BIOGLUE SURGICAL ADHESIVE IN SYRINGE DELIVERY SYSTEM (MODEL BG3500)
    PMA Number
    P010003
    Supplement Number
    S003
    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
    May 3, 2004
    Date Received
    March 17, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DISPOSABLE DUAL-BARREL PISTON-DRIVEN SYRINGE DISPENSING SYSTEM AS AN ALTERNATE TO THE CURRENT DUAL-BARREL REUSABLE RATCHETING PISTON-DRIVEN CARTRIDGE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BG3500 AND IS INDICATED FOR USE AS AN ADJUNCT TO STANDARD METHODS OF ACHIEVING HEMOSTASIS (SUCH AS SUTURES AND STAPLES) IN ADULT PATIENTS IN OPEN SURGICAL REPAIR OF LARGE VESSELS (SUCH AS AORTA, FEMORAL, AND CAROTID ARTERIES).

    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