BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Occluding, Vascular, Permanent

    PMA: P140018 · Supplement: S017 · Decision Dec 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Agent, Occluding, Vascular, Permanent
    Trade Name
    VenaSeal Closure System
    PMA Number
    P140018
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    PJQ
    Generic Name
    Agent, occluding, vascular, permanent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 20, 2019
    Date Received
    September 25, 2019
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change to the de-nesting coating agent added to the polyethylene terephthalate glycol (PET-G) film component of the packaging.

    Classifications

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

    Product Code Device Name
    PJQ Agent, Occluding, Vascular, Permanent