{
  "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": "P980003",
      "supplement_number": "S092",
      "applicant": "Boston Scientific Corp",
      "street_1": "150 Baytech Dr.",
      "street_2": "",
      "city": "San Jose",
      "state": "CA",
      "zip": "95134",
      "zip_ext": "",
      "generic_name": "Cardiac ablation percutaneous catheter",
      "trade_name": "Chilli II Cooled Ablation Catheter and Cable",
      "product_code": "LPB",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2020-03-12",
      "decision_date": "2020-05-19",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for a manufacturing site located at Boston Scientific Corp. in Ballybrit Business Park Galway, Ireland for sterilization.",
      "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"
      }
    }
  ]
}