{
  "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": "S928",
      "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",
      "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": "2026-07-07",
      "decision_date": "2026-07-31",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "changes to cleaning process and revising acceptance criteria for final visual inspection of hybrid subassembly",
      "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"
        ]
      }
    }
  ]
}