BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glue, Surgical, Arteries

    PMA: P010003 · Supplement: S027 · Decision Aug 21, 2017
    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
    S027
    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
    August 21, 2017
    Date Received
    July 24, 2017
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to establish a minimum seal width specification for the outer-most pouches of BioGlue and BioGlue accessories.

    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