{
  "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": 21
    }
  },
  "results": [
    {
      "pma_number": "P040003",
      "supplement_number": "",
      "applicant": "Insightec, Ltd.",
      "street_1": "4851 Lbj Frwy",
      "street_2": "Suite 400",
      "city": "Dallas",
      "state": "TX",
      "zip": "75244",
      "zip_ext": "",
      "generic_name": "Ablation system, high intensity focused ultrasound (HIFU), MR-guided",
      "trade_name": "EXABLATE 2000 SYSTEM",
      "product_code": "NRZ",
      "advisory_committee": "OB",
      "advisory_committee_description": "Obstetrics/Gynecology",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "Y",
      "date_received": "2004-01-27",
      "decision_date": "2004-10-22",
      "docket_number": "05M-0473",
      "fed_reg_notice_date": "2005-11-28",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE EXABLATE 2000 SYSTEM.  THE DEVICE IS INDICATED FOR ABLATION OF UTERINE FIBROID TISSUE IN PRE-OR PERI-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE.  PATIENTS MUST HAVE A UTERINE SIZE OF LESS THAN 24 WEEKS AND HAVE COMPLETED CHILD BEARING.",
      "openfda": {
        "registration_number": [
          "9615058"
        ],
        "fei_number": [
          "3003105983"
        ],
        "device_name": "Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}