{
  "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": 1
    }
  },
  "results": [
    {
      "pma_number": "P920015",
      "supplement_number": "S307",
      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "Ms Mvs11",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Permanent defibrillator electrodes",
      "trade_name": "MEDTRONIC(R) TRANSVENE LEAD SYSTEM",
      "product_code": "NVY",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2026-07-30",
      "decision_date": "2026-08-19",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "the implementation of a new Controlled Environment Area at the Medtronic Bakken Research Center",
      "openfda": {
        "device_name": "Permanent Defibrillator Electrodes",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3003276151",
          "9616693",
          "3002807561",
          "3006705815",
          "2649622",
          "2017865",
          "3011120183",
          "2648729",
          "3014461810",
          "9610139",
          "3016678045",
          "3015453963",
          "2124215",
          "3009380063",
          "3008494315",
          "2011171",
          "1225687",
          "1000121056",
          "3008973940",
          "2183787",
          "3003932293",
          "3002807314",
          "3010273872",
          "3018094310",
          "1028232",
          "1828132",
          "2030624",
          "3013288201",
          "2032521",
          "2182208",
          "3004105270",
          "3003120897",
          "1423662",
          "3004961578",
          "9614453",
          "2134604"
        ],
        "fei_number": [
          "3003276151",
          "3002618605",
          "3002807561",
          "3006705815",
          "2649622",
          "3001451463",
          "2017865",
          "3011120183",
          "2648729",
          "3014461810",
          "3016678045",
          "3015453963",
          "2124215",
          "3000206435",
          "3009380063",
          "3003574398",
          "2011171",
          "1000121056",
          "3008973940",
          "3002807576",
          "2183787",
          "3003932293",
          "3008377825",
          "3002807314",
          "3002806500",
          "3010273872",
          "3002623849",
          "3018094310",
          "1028232",
          "1828132",
          "3013288201",
          "2182208",
          "3004105270",
          "3003120897",
          "3004961578",
          "3000215273"
        ]
      }
    }
  ]
}