{
  "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": "P010031",
      "supplement_number": "S911",
      "applicant": "Medtronic Cardiac Rhythm Disease Management",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)",
      "trade_name": "Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D",
      "product_code": "NIK",
      "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": "2025-12-15",
      "decision_date": "2026-01-05",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "new equipment to automate the removal of photoresist material",
      "openfda": {
        "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "9610139",
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3009380063",
          "1000165971",
          "3003120897",
          "3005941719",
          "2133641",
          "3008159616",
          "3033257494",
          "1028232",
          "2648729",
          "3005334138",
          "3008494315",
          "3013500228",
          "9614453",
          "3012552532",
          "9616693",
          "3015453963",
          "2032521",
          "3002806603",
          "3013288201",
          "3013596024",
          "3018094310"
        ],
        "fei_number": [
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3009380063",
          "1000165971",
          "3000203466",
          "3003120897",
          "3008159616",
          "3002806500",
          "3033257494",
          "1028232",
          "2648729",
          "3005334138",
          "3002807111",
          "3013500228",
          "3012552532",
          "3002618605",
          "3003574398",
          "3015453963",
          "3002806603",
          "3013288201",
          "3013596024",
          "3008377825",
          "3018094310",
          "3002807576"
        ]
      }
    }
  ]
}