BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder (Atrial)

    PMA: P200032 · Decision Dec 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Transcatheter Septal Occluder (Atrial)
    Trade Name
    Occlutech® ASD Occluder and Occlutech® Pistol Pusher
    PMA Number
    P200032
    Device Class
    FDA Class 3
    Product Code
    OZG
    Generic Name
    Transcatheter septal occluder (atrial)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 29, 2023
    Date Received
    July 7, 2020
    Expedited Review
    N
    Docket Number
    24M-0759

    Advisory Committee Statement

    The Occlutech ASD Occluder is a medical device intended for transcatheter closure of ostium secundum-type atrial septal defects (ASD). Patients indicated for ASD closure have:• Echocardiographic evidence of ostium secundum-type ASD, • Clinical evidence of right ventricular (RV) volume overload (hemodynamically significant left-to-right shunt with Qp / Qs ? 1.5 or RV enlargement).The Occlutech Pistol Pusher is a percutaneous, transcatheter pusher system designed for the delivery of the Occlutech ASD Occluder to the implantation area. It is used via a minimally invasive catheter delivery system technique.

    Classifications

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

    Product Code Device Name
    OZG Transcatheter Septal Occluder (Atrial)