{
  "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": "P010012",
      "supplement_number": "S611",
      "applicant": "Boston Scientific Corp",
      "street_1": "4100 Hamline Ave. N",
      "street_2": "",
      "city": "St Paul",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)",
      "trade_name": "ACUITY™ SPIRAL, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L",
      "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": "2026-05-11",
      "decision_date": "2026-06-09",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "an alternative vapor degreasing solvent used by a supplier, Integer Brooklyn Park",
      "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"
        ]
      }
    }
  ]
}