{
  "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": 2
    }
  },
  "results": [
    {
      "pma_number": "P250034",
      "supplement_number": "S001",
      "applicant": "Novocure, GmbH",
      "street_1": "Neuhofstrasse 21",
      "street_2": "",
      "city": "Baar",
      "state": "",
      "zip": "6340",
      "zip_ext": "",
      "generic_name": "Low Electric Field Generator for Pancreatic Cancer Treatment",
      "trade_name": "Optune Pax®",
      "product_code": "SHC",
      "advisory_committee": "SU",
      "advisory_committee_description": "General, Plastic Surgery",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2026-04-24",
      "decision_date": "2026-07-01",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for extending the shelf life of the sterilized ITE transducer array from nine months to twelve months.",
      "openfda": {
        "registration_number": [
          "3009453079",
          "3009746061",
          "3010457505",
          "3003639781",
          "3009306483",
          "8043792"
        ],
        "fei_number": [
          "3009453079",
          "3009746061",
          "3002808269",
          "3010457505",
          "3003639781",
          "3009306483"
        ],
        "device_name": "Low Electric Field Generator For Pancreatic Cancer Treatment",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}