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

    Sealant, Polymerizing

    PMA: P150016 · Supplement: S008 · Decision Jan 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    Tridyne Vascular Sealant
    PMA Number
    P150016
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 2, 2018
    Date Received
    November 28, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changes to the manufacturing of the extended applicator tip, assembly/sealing/packaging, labeling processes, and environmental controls of TRIDYNE Vascular Sealant.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NBE Sealant, Polymerizing