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

    Agent, Occluding, Vascular, Permanent

    PMA: P140018 · Supplement: S028 · Decision Oct 6, 2021
    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
    S028
    Device Class
    FDA Class 3
    Product Code
    PJQ
    Generic Name
    Agent, occluding, vascular, permanent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 6, 2021
    Date Received
    September 23, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Use of an alternative biological indicator (BI) for use in sterilization of the VenaSeal Closure System.

    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