BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Occluding, Vascular, Permanent

    PMA: P140018 · Decision Feb 20, 2015
    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
    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
    February 20, 2015
    Date Received
    August 25, 2014
    Expedited Review
    N
    Docket Number
    15M-0690

    Advisory Committee Statement

    APPROVAL FOR THE VENASEAL CLOSURE SYSTEM. THIS DEVICE IS INDICATED FOR THE PERMANENT CLOSURE OF LOWER EXTREMITY SUPERFICIAL TRUNCAL VEINS, SUCH AS THE GREAT SAPHENOUS VEIN (GSV), THROUGH ENDOVASCULAR EMBOLIZATION WITH COAPTATION. VENASEAL IS INTENDED FOR USE IN ADULTS WITH CLINICALLY SYMPTOMATIC VENOUS REFLUX AS DIAGNOSED BY DUPLEX ULTRASOUND (DUS).

    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