{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "pma_number": "P010012",
      "supplement_number": "S552",
      "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": "RESONATE™ HF, RESONATE™, RESONATE™ X4, MOMENTUM™, MOMENTUM™ X4, VIGILIANT™, VIGILIANT™ X4",
      "product_code": "NIK",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Postapproval Study Protocol",
      "expedited_review_flag": "N",
      "date_received": "2022-03-23",
      "decision_date": "2022-08-26",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the MANAGE-HF Post Approval Study (PAS) to be transitioned to the HeartLogic PAS Analysis Plan.",
      "openfda": {
        "registration_number": [
          "1028232",
          "3009380063",
          "3013500228",
          "2182208",
          "3008494315",
          "9616693",
          "3013288201",
          "3005334138",
          "3002806603",
          "3033257494",
          "3006705815",
          "2124215",
          "3008159616",
          "2648729",
          "1000165971",
          "3005941719",
          "3018094310",
          "9614453",
          "2017865",
          "3003120897",
          "3015453963",
          "3013596024",
          "2133641",
          "2032521",
          "3012552532",
          "9610139"
        ],
        "fei_number": [
          "1028232",
          "3002807576",
          "3009380063",
          "3013500228",
          "3002807111",
          "2182208",
          "3002806500",
          "3003574398",
          "3013288201",
          "3005334138",
          "3002806603",
          "3033257494",
          "3006705815",
          "2124215",
          "3008159616",
          "2648729",
          "3002618605",
          "3000203466",
          "1000165971",
          "3018094310",
          "2017865",
          "3003120897",
          "3008377825",
          "3015453963",
          "3013596024",
          "3012552532"
        ],
        "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}