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

    Sealant, Polymerizing

    PMA: P150016 · Supplement: S026 · Decision Jun 18, 2025
    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
    S026
    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
    June 18, 2025
    Date Received
    May 30, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    For the reduction of TM-0080 Particulate Testing for PEG Filled Cartridges (78-8110-3501-9) and to qualify an alternate supplier (Neomend, Inc.) to perform Sodium Concentration Testing (TM-0056 REV.1).

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing