BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder (Atrial)

    PMA: P200032 · Supplement: S001 · Decision Jun 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Transcatheter Septal Occluder (Atrial)
    Trade Name
    Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack
    PMA Number
    P200032
    Supplement Number
    S001
    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
    June 7, 2024
    Date Received
    March 8, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for extending the shelf-life for both the Occlutech ASD Occluder (ASD) and the Occlutech Pistol Pusher (OPP) to 5 years

    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)