{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 12
    }
  },
  "results": [
    {
      "pma_number": "P250012",
      "supplement_number": "S010",
      "applicant": "Medtronic Minimed, Inc.",
      "street_1": "18000 Devonshire St.",
      "street_2": "",
      "city": "Northridge",
      "state": "CA",
      "zip": "91325",
      "zip_ext": "",
      "generic_name": "Sensor, Glucose, Invasive, Component of automated insulin delivery system",
      "trade_name": "Simplera and Simplera Sync",
      "product_code": "SFI",
      "advisory_committee": "CH",
      "advisory_committee_description": "Clinical Chemistry",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2026-04-27",
      "decision_date": "2026-05-26",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "to increase the capacity for the degassing of Simplera and Simplera Sync sensors by adding an additional degassing aeration room (Degassing Room #3) at a sterilization facility. The Simplera sensor is a component of the Simplera system. The Simplera Sync sensor is a component of the MiniMed 780G system. The Simplera Sync sensor is also approved for use with compatible cleared MiniMed devices",
      "openfda": {
        "registration_number": [
          "3042027705",
          "2032227"
        ],
        "fei_number": [
          "3042027705",
          "3003166194"
        ],
        "device_name": "Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}