{
  "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": "P040042",
      "supplement_number": "S053",
      "applicant": "Irvine Biomedical,Inc.(Ibi)",
      "street_1": "2375 Morse Ave.",
      "street_2": "",
      "city": "Irvine",
      "state": "CA",
      "zip": "92614",
      "zip_ext": "",
      "generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
      "trade_name": "Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable",
      "product_code": "OAD",
      "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": "2022-10-28",
      "decision_date": "2022-12-16",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for Sterigenics Utah as an alternate EO sterilization vendor for Irvine EP cables.",
      "openfda": {
        "registration_number": [
          "3017060084",
          "3007695959",
          "3007029079",
          "3006634485",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "1643817",
          "3011120183",
          "2028523",
          "9673241",
          "3001592626",
          "2124215",
          "2182269",
          "3000279201",
          "3010291427",
          "1650907",
          "1000121056",
          "3008328679",
          "3002807314",
          "2030404",
          "3010273872",
          "3015537323",
          "3004859241",
          "1721504",
          "3009243923",
          "3019807891",
          "3013581838",
          "3012520654",
          "3012260771",
          "3001763079",
          "3004016520",
          "3012179728",
          "3016245399",
          "3010280625",
          "2182208",
          "1319639",
          "1721983",
          "3010705768",
          "3004105270",
          "2184149",
          "9681260",
          "3013300026",
          "2032112",
          "9680001",
          "2032098",
          "3012552532",
          "3013403214",
          "9612164"
        ],
        "fei_number": [
          "3017060084",
          "3007695959",
          "3007029079",
          "3006634485",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "1643817",
          "3011120183",
          "1000138054",
          "3003248396",
          "3001592626",
          "2124215",
          "2182269",
          "1000519796",
          "3000279201",
          "3010291427",
          "3002681132",
          "1000121056",
          "3008328679",
          "3002807314",
          "3003076831",
          "3010273872",
          "3002808445",
          "3015537323",
          "3004859241",
          "3002806434",
          "1721504",
          "3009243923",
          "3019807891",
          "1000064530",
          "3013581838",
          "3012520654",
          "3012260771",
          "3002806565",
          "3001763079",
          "1000125147",
          "1000139754",
          "3004016520",
          "3012179728",
          "3016245399",
          "3010280625",
          "2182208",
          "3010705768",
          "3013300026",
          "3003058448",
          "3004105270",
          "3012552532",
          "3013403214"
        ],
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}