BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glue, Surgical, Arteries

    PMA: P010003 · Supplement: S001 · Decision Jul 29, 2002
    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
    S001
    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
    July 29, 2002
    Date Received
    May 3, 2002
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) ADDING AN ADDITIONAL VENDOR, DOMNICK HUNTER, PLC, FOR THE 0.2 UM-FILTER TO FILTER BULK COMPONENT SOLUTIONS, AND 2) ADDING A SOLUTION MIXING SYSTEM FOR THE BOVINE SERUM ALBUMIN BULK SOLUTION FOR BAGS UP TO 20L IN CAPACITY.

    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