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

    Agent, Occluding, Vascular, Permanent

    PMA: P140018 · Supplement: S002 · Decision Jul 27, 2016
    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
    S002
    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
    July 27, 2016
    Date Received
    June 27, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Implementation of an alternative test method for determination of adhesive stabilizer concentration in the n-butyl cyanoacrylate (nBCA) monomer at incoming inspection as well as in the VenaSeal adhesive formulation.

    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