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

    Transcatheter Septal Occluder (Atrial)

    PMA: P200032 · Supplement: S002 · Decision Apr 18, 2025
    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
    Supplement Number
    S002
    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
    April 18, 2025
    Date Received
    March 21, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to add a new manufacturing location, ‘BIZ’ (Bioinstrumentezentrum), within the same currently-approved establishment (under same FEI) for the manufacture of the Occlutech ASD Occluder

    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)