BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glue, Surgical, Arteries

    PMA: P010003 · Supplement: S015 · Decision May 12, 2010
    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
    S015
    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 12, 2010
    Date Received
    April 30, 2010
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CLARIFICATION REGARDING ONE OF THE WARNINGS IN THE INSTRUCTIONS FOR USE (IFU).

    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