{
  "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": "2026-10-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P240036",
      "supplement_number": "S004",
      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Permanent defibrillator electrodes",
      "trade_name": "OmniaSecure™ MRI SureScan™ Lead Model 3930M",
      "product_code": "NVY",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2025-12-09",
      "decision_date": "2026-03-09",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for updated indications and labeling changes with Left Bundle Branch Area Pacing (LBBAP) application for the OmniaSecure™ MRI SureScan™ 3930M lead",
      "openfda": {
        "device_name": "Permanent Defibrillator Electrodes",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "9610139",
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3009380063",
          "2649622",
          "2011171",
          "3011120183",
          "3003932293",
          "3014461810",
          "3016678045",
          "3003276151",
          "3003120897",
          "2030624",
          "1828132",
          "3002807561",
          "1028232",
          "2648729",
          "3008494315",
          "3004961578",
          "1225687",
          "2134604",
          "9614453",
          "3008973940",
          "9616693",
          "3015453963",
          "2032521",
          "1423662",
          "3010273872",
          "3013288201",
          "1000121056",
          "2183787",
          "3002807314",
          "3018094310",
          "3004105270"
        ],
        "fei_number": [
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3009380063",
          "2649622",
          "2011171",
          "3011120183",
          "3003932293",
          "3014461810",
          "3016678045",
          "3003276151",
          "3003120897",
          "1828132",
          "3002806500",
          "3002807561",
          "1028232",
          "2648729",
          "3004961578",
          "3008973940",
          "3002618605",
          "3003574398",
          "3015453963",
          "3001451463",
          "3000215273",
          "3000206435",
          "3010273872",
          "3013288201",
          "1000121056",
          "2183787",
          "3002623849",
          "3008377825",
          "3002807314",
          "3018094310",
          "3004105270",
          "3002807576"
        ]
      }
    }
  ]
}