{
  "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": "P980016",
      "supplement_number": "S949",
      "applicant": "Medtronic Cardiac Rhythm Disease Management",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "Ms Mvs11",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Implantable cardioverter defibrillator (non-CRT)",
      "trade_name": "Evera MRI DF-1 ICD DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DD",
      "product_code": "LWS",
      "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": "2026-01-16",
      "decision_date": "2026-02-12",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "manufacturing and test process improvements for integrated circuits",
      "openfda": {
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "9610139",
          "2022502",
          "2124215",
          "2182208",
          "2017865",
          "3006705815",
          "3009380063",
          "3004209178",
          "1000165971",
          "2011171",
          "2649622",
          "3011120183",
          "3003932293",
          "3014461810",
          "3003276151",
          "3003120897",
          "2135338",
          "2133641",
          "2030624",
          "1828132",
          "3008159616",
          "3033257494",
          "3002807561",
          "1028232",
          "2648729",
          "3005334138",
          "3008494315",
          "2183744",
          "3004961578",
          "1225687",
          "3013500228",
          "3004593495",
          "9614453",
          "3012552532",
          "3008973940",
          "9616693",
          "3010288227",
          "3015453963",
          "2032521",
          "1423662",
          "3013674629",
          "3008988055",
          "3010273872",
          "3015544746",
          "3002806603",
          "3013288201",
          "1000121056",
          "3013596024",
          "2183787",
          "3002807314",
          "3018094310",
          "3004105270"
        ],
        "fei_number": [
          "2022502",
          "2124215",
          "2182208",
          "2017865",
          "3004369318",
          "3006705815",
          "3009380063",
          "1000165971",
          "2011171",
          "2649622",
          "3011120183",
          "3003932293",
          "3014461810",
          "3000203466",
          "3003276151",
          "3003120897",
          "1828132",
          "3008159616",
          "3002806500",
          "3033257494",
          "3002807561",
          "1028232",
          "2648729",
          "3005334138",
          "2183744",
          "3004961578",
          "3013500228",
          "3004593495",
          "3005700659",
          "3012552532",
          "3008973940",
          "3002618605",
          "3003574398",
          "3010288227",
          "3015453963",
          "3001451463",
          "3000215273",
          "3000206435",
          "3013674629",
          "3008988055",
          "3010273872",
          "3015544746",
          "3002806603",
          "3013288201",
          "1000121056",
          "3013596024",
          "2183787",
          "3008377825",
          "3002807314",
          "3018094310",
          "3004105270",
          "3002807576"
        ]
      }
    }
  ]
}