BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P150016 · Supplement: S005 · Decision Jul 6, 2017
    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
    S005
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 6, 2017
    Date Received
    April 10, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to modify the storage conditions of Tridyne Vascular Sealant (Tridyne VS) from refrigerated conditions 2-8°C (36-46°F) to include a controlled ambient temperature storage excursion of 8-25°C (46-77°F) for a period of up to 35 days within the approved shelf life of 24 months.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing