BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Occluding, Vascular, Permanent

    PMA: P140018 · Supplement: S033 · Decision Apr 3, 2023
    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
    S033
    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
    April 3, 2023
    Date Received
    July 29, 2022
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change to the biological indicator used during the sterilization of the VenaSeal adhesive at the Medtronic Galway facility.

    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