BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glue, Surgical, Arteries

    PMA: P010003 · Supplement: S006 · Decision Apr 13, 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
    S006
    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
    April 13, 2006
    Date Received
    July 25, 2005
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO MANUFACTURING SITES: 1) CENTURION STERILIZATION SERVICES, PART OF TRI-STATE HOSPITAL SUPPLY, SALISBURY, NORTH CAROLINA FOR THE STERILIZATION OF BIOGLUE EXTENDER TIPS; AND 2) COMMAND MEDICAL PRODUCTS, ORMOND BEACH, FLORIDA AS A COMPONENT ASSEMBLER.

    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