{
  "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": "2026-09-14",
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  "results": [
    {
      "pma_number": "P040003",
      "supplement_number": "S018",
      "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": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2016-05-10",
      "decision_date": "2016-08-26",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for change to the ExAblate system to comply with the European directive 2002/95/EC and 2011/65/EU in relation to Restriction of Hazardous Substance (RoHS).",
      "openfda": {
        "device_name": "Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "9615058"
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        "fei_number": [
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