BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Glue, Surgical, Arteries

    PMA: P010003 · Supplement: S022 · Decision May 4, 2016
    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
    S022
    Device Class
    FDA Class 3
    Product Code
    MUQ
    Generic Name
    Glue, surgical, arteries
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 4, 2016
    Date Received
    April 4, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to the frequency of the bioburden assessments from quarterly to annually for BioGlue Accessories that undergo Ethylene Oxide (EO) sterilization, a modification to the Limulus Amebocyte Lysate (LAL) test method for BioGlue to include agitation during the extraction process and change the dilution to test the BioGlue extract, and to eliminate the quarterly autoclave cycle verification and the quarterly issuance of Certificates of Completion for the autoclaves used in production and microbiology.

    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