BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder (Atrial)

    PMA: P200032 · Supplement: S005 · Decision May 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Transcatheter Septal Occluder (Atrial)
    Trade Name
    Occlutech Pistol Pusher
    PMA Number
    P200032
    Supplement Number
    S005
    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
    May 11, 2026
    Date Received
    March 4, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a revised Instructions for Use (IFU) for the Occlutech Pistol Pusher (OPP). The updated IFU introduces generalized handling instructions to standardize procedures across Occlutech devices

    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)