{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Occlutech ASD Occluder and Occlutech Pistol Pusher"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3014616394",
        "fei_number": "3014616394",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Occlutech GmbH",
        "address_line_1": "Winzerlaer Strasse 2",
        "address_line_2": "",
        "city": "Jena Thuringia",
        "state_code": "",
        "iso_country_code": "DE",
        "zip_code": "",
        "postal_code": "07745",
        "us_agent": {
          "name": "Christine Lee",
          "business_name": "OCCLUTECH US LLC",
          "bus_phone_area_code": "404",
          "bus_phone_num": "4227739",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "christine.lee@occlutech.com",
          "address_line_1": "9325 Upland Lane North",
          "address_line_2": "Suite 315",
          "city": "Maple Grove",
          "state_code": "MN",
          "iso_country_code": "US",
          "zip_code": "55369",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Occlutech Holding AG",
          "owner_operator_number": "10084004",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Feldstrasse 22",
            "address_2": "",
            "city": "Schaffhausen",
            "state_code": "CH-SH",
            "state_province": "",
            "iso_country_code": "CH",
            "postal_code": "8200"
          }
        }
      },
      "pma_number": "P200032",
      "k_number": "",
      "products": [
        {
          "product_code": "OZG",
          "created_date": "2024-01-17",
          "owner_operator_number": "10084004",
          "exempt": "",
          "openfda": {
            "pma_number": [
              "P200032"
            ],
            "device_name": "Transcatheter Septal Occluder (Atrial)",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        }
      ]
    }
  ]
}