BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P150016 · Supplement: S009 · Decision Aug 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip
    PMA Number
    P150016
    Supplement Number
    S009
    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
    August 10, 2018
    Date Received
    November 28, 2017
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to implement changes to the human serum albumin (HSA) filling and polyethylene glycol (PEG) filling processes.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing