{
  "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": "2026-10-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P040042",
      "supplement_number": "S060",
      "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": "Therapy™ Dual-8™ Ablation Catheter",
      "product_code": "OAD",
      "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": "2026-08-07",
      "decision_date": "2026-09-03",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "to add an alternate epoxy in the manufacture of the temperature sensor",
      "openfda": {
        "registration_number": [
          "3013403214",
          "2032112",
          "2124215",
          "9681260",
          "2182208",
          "3000279201",
          "3007695959",
          "1928237",
          "2182269",
          "3012179728",
          "3011120183",
          "3010280625",
          "3009243923",
          "3017060084",
          "3001763079",
          "9680001",
          "3007029079",
          "1721983",
          "3004016520",
          "2032098",
          "2030404",
          "3015537323",
          "1721504",
          "3010291427",
          "3005334138",
          "3008452825",
          "3012520654",
          "3006634485",
          "1319639",
          "3019807891",
          "9673241",
          "3010653929",
          "1721686",
          "3016245399",
          "1650907",
          "3012260771",
          "3012552532",
          "9612164",
          "1643817",
          "3010273872",
          "2184149",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3013581838",
          "2028523",
          "3002807314",
          "3008093809",
          "3004105270",
          "3001592626",
          "3008328679"
        ],
        "fei_number": [
          "3013403214",
          "2182208",
          "2124215",
          "3000279201",
          "3007695959",
          "3002806565",
          "1928237",
          "2182269",
          "3002806434",
          "3012179728",
          "3011120183",
          "3010280625",
          "3009243923",
          "3017060084",
          "1000139754",
          "3001763079",
          "3007029079",
          "3004016520",
          "1000519796",
          "3015537323",
          "1721504",
          "3010291427",
          "3005334138",
          "3008452825",
          "3002808445",
          "1000125147",
          "3012520654",
          "3006634485",
          "3003076831",
          "3002681132",
          "3019807891",
          "3010653929",
          "1721686",
          "3016245399",
          "3012260771",
          "3012552532",
          "3003248396",
          "1643817",
          "1000138054",
          "3010273872",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3013581838",
          "3002807314",
          "3008093809",
          "3003058448",
          "1000064530",
          "3004105270",
          "3001592626",
          "3008328679"
        ],
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}