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

    Transcatheter Septal Occluder (Atrial)

    PMA: P200032 · Supplement: S004 · Decision Dec 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    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
    S004
    Device Class
    FDA Class 3
    Product Code
    OZG
    Generic Name
    Transcatheter septal occluder (atrial)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 18, 2025
    Date Received
    November 14, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    consolidation of manufacturing operations for the Occlutech ASD Occluder by moving all remaining production activities and equipment from your 'TIP' (Technologie-und Innovationspark) facility to your 'BIZ' (Bioinstrumentezentrum) facility

    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)