{
  "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": "P990071",
      "supplement_number": "S054",
      "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": "SmartAblate Irrigation Tubing Set and nGEN Pump",
      "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": "2022-05-18",
      "decision_date": "2022-06-08",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "Change in the location for inspection of the SmartAblate Irrigation Tubing Set and nGEN Pump from the Irwindale, CA site to the Irvine, CA site.",
      "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"
      }
    }
  ]
}