{
  "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": "P040036",
      "supplement_number": "S079",
      "applicant": "Biosense Webster, Inc.",
      "street_1": "31 Technology Dr., Suite 200",
      "street_2": "",
      "city": "Irvine",
      "state": "CA",
      "zip": "92618",
      "zip_ext": "",
      "generic_name": "Cardiac ablation percutaneous catheter",
      "trade_name": "Navistar Thermocool, EZ Steer Thermocool Nav Bi- Directional, Navistar RMT Thermocool, Thermocool SF Nav Bi-directional,",
      "product_code": "LPB",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Special (Immediate Track)",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2021-03-02",
      "decision_date": "2021-04-07",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the addition of warnings from other catheter lines and the clarification of existing warnings and instructions.",
      "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"
      }
    }
  ]
}