{
  "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,
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  "results": [
    {
      "pma_number": "P160007",
      "supplement_number": "S047",
      "applicant": "Medtronic Minimed",
      "street_1": "18000 Devonshire St.",
      "street_2": "",
      "city": "Northridge",
      "state": "CA",
      "zip": "91325",
      "zip_ext": "",
      "generic_name": "Sensor, glucose, invasive, non-adjunctive",
      "trade_name": "Simplera™ System",
      "product_code": "PQF",
      "advisory_committee": "CH",
      "advisory_committee_description": "Clinical Chemistry",
      "supplement_type": "Panel Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2023-02-15",
      "decision_date": "2024-07-24",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the Simplera system. The Simplera system is a real-time continuous glucose monitoring (CGM) system indicated for the management of diabetes in persons ages 18 years and older. The Simplera system does not require calibration and is designed to replace fingerstick blood glucose (BG) testing for diabetes treatment decisions, unless otherwise indicated. Interpretation of the Simplera system results should be based on the glucose trends and several sequential sensor readings over time.",
      "openfda": {
        "registration_number": [
          "2032227",
          "3009882464",
          "3016540876",
          "3042027705",
          "3007981285",
          "3010291427",
          "3013756811"
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          "3016540876",
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        ],
        "device_name": "Sensor, Glucose, Invasive, Non-Adjunctive",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}