BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glue, Surgical, Arteries

    PMA: P010003 · Supplement: S005 · Decision Jan 20, 2006
    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
    S005
    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
    January 20, 2006
    Date Received
    April 14, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) ADDITION OF TWO SPREADER TIPS, SIZE 12 MM AND 16 MM; 2) ADDITION OF A GREEN COLORANT (FDA 21 CFR 178.3297 COMPLIANT MBPP 11962) TO THE COLLAR OF THE MIXING TIP FOR EASIER VISUALIZATION OF THE MATING MECHANISM; 3) MODIFICATION (BLUNTING THE END RATHER THAN POINTED TIP) OF THE MIXING CHAMBER STEM END TO ACCEPT THE NEW APPLICATOR TIPS; 4) MODIFICATION OF THE COLLAR FORMULATION FOR THE POLYPROPYLENE; 5) USE OF A NEW MATERIAL FOR THE SPREADER EXTENSION; AND 6) MODIFICATION OF THE STEM MATERIAL.

    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