{
  "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",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 42
    }
  },
  "results": [
    {
      "pma_number": "P150038",
      "supplement_number": "S037",
      "applicant": "Insightec",
      "street_1": "5 Nahum Heth St.",
      "street_2": "",
      "city": "Tirat Carmel",
      "state": "",
      "zip": "39120",
      "zip_ext": "",
      "generic_name": "MR-guided focused ultrasound system",
      "trade_name": "Exablate Model 4000 Type-1 System",
      "product_code": "POH",
      "advisory_committee": "NE",
      "advisory_committee_description": "Neurology",
      "supplement_type": "Panel Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2024-07-16",
      "decision_date": "2025-07-03",
      "docket_number": "25M-2196",
      "fed_reg_notice_date": "2025-07-10",
      "decision_code": "APPR",
      "ao_statement": "The Exablate Neuro is intended indicated for use in the unilateral pallidothalamic tractotomy of advanced idiopathic Parkinson’s Disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinson’s disease medication treatment, and in the staged (by at least 6 months from the first pallidothalamic tractotomy), unilateral pallidothalamic tractotomy of idiopathic Parkinson’s Disease with medication-refractory motor complications of their contralateral side that was not previously treated in the first unilateral pallidothalamic tractotomy. Patients must be at least age 30. The designated area in the brain responsible for the motor complications symptoms (pallidothalamic tract) must be identified and accessible for targeted thermal ablation by the Exablate device.",
      "openfda": {
        "device_name": "Mr-Guided Focused Ultrasound System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3008729892",
          "3012635238",
          "3005238200",
          "9615058"
        ],
        "fei_number": [
          "3012635238",
          "3003105983",
          "3005238200",
          "3002807555"
        ]
      }
    }
  ]
}