{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P920047",
      "supplement_number": "S121",
      "applicant": "Boston Scientific Corp",
      "street_1": "4100 Hamline Ave. N",
      "street_2": "",
      "city": "St Paul",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Cardiac ablation percutaneous catheter",
      "trade_name": "IntellaNav ST Temperature Ablation Catheter",
      "product_code": "LPB",
      "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": "2020-01-22",
      "decision_date": "2020-02-19",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "Updating weld process parameters to harmonize across multiple ablation catheter families.",
      "openfda": {
        "registration_number": [
          "3017060084",
          "3007695959",
          "3007029079",
          "3006634485",
          "3003084417",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "1643817",
          "2649622",
          "2028523",
          "3044156918",
          "9673241",
          "3001592626",
          "3003923762",
          "8020893",
          "2124215",
          "2182269",
          "1650907",
          "2135338",
          "1000121056",
          "2030404",
          "3010273872",
          "3015537323",
          "3004859241",
          "2029275",
          "3002648230",
          "1450662",
          "3009243923",
          "3019807891",
          "3012260771",
          "3006891611",
          "3001763079",
          "3012179728",
          "3010280625",
          "1313046",
          "1319639",
          "2182208",
          "3010705768",
          "1721983",
          "2184149",
          "9617601",
          "3004105270",
          "9681260",
          "3013300026",
          "2032112",
          "3011163668",
          "2648623",
          "9680001",
          "2032098",
          "9611665",
          "3012552532",
          "3013403214"
        ],
        "fei_number": [
          "3017060084",
          "3007695959",
          "3007029079",
          "3002534070",
          "3006634485",
          "3003084417",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "1643817",
          "2649622",
          "3044156918",
          "1000138054",
          "1000306431",
          "3003248396",
          "3001592626",
          "3003923762",
          "2124215",
          "2182269",
          "1000519796",
          "3002681132",
          "3005700659",
          "1000121056",
          "3003076831",
          "3002807095",
          "3010273872",
          "3002808445",
          "3002648230",
          "3015537323",
          "3004859241",
          "1450662",
          "3009243923",
          "3019807891",
          "3002807850",
          "1000064530",
          "3012260771",
          "3002806565",
          "3001763079",
          "1000125147",
          "1000139754",
          "3006891611",
          "3012179728",
          "3010280625",
          "1313046",
          "2182208",
          "3010705768",
          "3013300026",
          "3003058448",
          "3011163668",
          "2648623",
          "3004105270",
          "3012552532",
          "3013403214"
        ],
        "device_name": "Cardiac Ablation Percutaneous Catheter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}