{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 187
    }
  },
  "results": [
    {
      "pma_number": "P980022",
      "supplement_number": "S033",
      "applicant": "Medtronic Minimed",
      "street_1": "18000 Devonshire St.",
      "street_2": "",
      "city": "Northridge",
      "state": "CA",
      "zip": "91325",
      "zip_ext": "",
      "generic_name": "Sensor, glucose, invasive",
      "trade_name": "CARELINK PERSONAL SOFTWARE",
      "product_code": "MDS",
      "advisory_committee": "CH",
      "advisory_committee_description": "Clinical Chemistry",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2008-08-18",
      "decision_date": "2008-09-24",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL  FOR A CHANGE TO THE CARELINK PERSONAL THERAPYMANAGEMENT SOFTWARE FOR DIABETES (MMT-7333) THE CARELINK PERSONAL THERAPY MANAGEMENTSOFTWARE FOR DIABETES IS A NETWORK BASED SOFTWARE SYSTEM RESIDING ON A COMPUTER SERVER PLATFORM CONNECTED TO THE INTERNET. THE PURPOSE OF THIS SYSTEM IS TO TAKE INFORMATION TRANSMITTED FROM INSULIN PUMPS, CONTINUOUS GLUCOSE MONITORS AND GLUCOSE METERS, AND LOGBOOK DATA ENTERED BY THE PATIENT, AND TURN IT INTO MEDTRONIC CARELINK THERAPY MANAGEMENT SOFTWARE FOR DIABETES REPORTS.THE REPORTS PROVIDE INFORMATION THAT CAN BE USED TO IDENTIFY TRENDS AND TRACK DAILY ACTIVITIES; SUCH AS CARBOHYDRATES EATEN, MEAL TIME, INSULIN DELIVERY, AND BLOOD GLUCOSE READINGS. THE SOFTWAREVERSION 4.6 IS A REVISION TO IMPLEMENT SEVERAL FEATURE ENHANCEMENTS, WHICH INCLUDE A LOGBOOKDIARY REPORT, REMOVAL OF ROCHE ACCU-CHECK 'AVIVA' AND COMPACT PLUS METERS FROM METERLISTINGS DISPLAYED FOR USERS LOCATED IN COUNTRIES OTHER THAN U.S. AND CANADA, AND CONSOLIDATION OF THE HELP SYSTEM THAT SERVES AS INSTRUCTIONS FOR USE.",
      "openfda": {
        "registration_number": [
          "",
          "9710492",
          "2024024",
          "3013756811",
          "3007421145",
          "3007527549",
          "2032227",
          "3004139819",
          "3009171251",
          "3014498598",
          "3010893867",
          "2030598",
          "3006371704",
          "3009882464",
          "3007981285",
          "2954323",
          "2134850",
          "3007939342",
          "3002807314",
          "3042027705"
        ],
        "fei_number": [
          "",
          "2024024",
          "3013756811",
          "3007527549",
          "3006759904",
          "3002803444",
          "3004139819",
          "3014498598",
          "3004173703",
          "3010893867",
          "1000518731",
          "3003500908",
          "3003166194",
          "3006371704",
          "3009882464",
          "3007981285",
          "3007939342",
          "3002807314",
          "3003007876",
          "3042027705"
        ],
        "device_name": "Sensor, Glucose, Invasive",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}