{
  "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": "P960016",
      "supplement_number": "S093",
      "applicant": "St Jude Medical",
      "street_1": "14900 Minnetonka Ind Rd.",
      "street_2": "",
      "city": "Minnetonka",
      "state": "MN",
      "zip": "55345",
      "zip_ext": "",
      "generic_name": "Cardiac ablation percutaneous catheter",
      "trade_name": "Livewire™ TC XLS™",
      "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": "2025-12-17",
      "decision_date": "2026-01-15",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "an alternate vapor degreaser which is used as a processing aid to remove metalworking cutting fluid on patient-contacting tip electrodes and electrode rings during manufacturing",
      "openfda": {
        "registration_number": [
          "3013403214",
          "2032112",
          "2124215",
          "9681260",
          "2182208",
          "3007695959",
          "1928237",
          "2182269",
          "2649622",
          "9611665",
          "3012179728",
          "3010280625",
          "3009243923",
          "3017060084",
          "3001763079",
          "9680001",
          "3007029079",
          "1450662",
          "9617601",
          "1721983",
          "2135338",
          "2032098",
          "2030404",
          "3015537323",
          "3002648230",
          "8020893",
          "1313046",
          "3005334138",
          "3008452825",
          "3006634485",
          "1319639",
          "3003923762",
          "3019807891",
          "9673241",
          "3010653929",
          "1721686",
          "3003084417",
          "1650907",
          "3012260771",
          "3006891611",
          "3012552532",
          "2648623",
          "3011163668",
          "1643817",
          "3010273872",
          "2184149",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3044156918",
          "2028523",
          "3008093809",
          "3004105270",
          "3001592626",
          "2029275"
        ],
        "fei_number": [
          "3013403214",
          "2182208",
          "2124215",
          "3002534070",
          "3007695959",
          "3002806565",
          "1928237",
          "2182269",
          "1000306431",
          "2649622",
          "3012179728",
          "3010280625",
          "3009243923",
          "3017060084",
          "1000139754",
          "3001763079",
          "3007029079",
          "1450662",
          "1000519796",
          "3015537323",
          "3002648230",
          "1313046",
          "3005334138",
          "3008452825",
          "3002808445",
          "3002807095",
          "1000125147",
          "3006634485",
          "3003923762",
          "3003076831",
          "3002681132",
          "3019807891",
          "3010653929",
          "1721686",
          "3003084417",
          "3012260771",
          "3006891611",
          "3005700659",
          "3012552532",
          "3003248396",
          "2648623",
          "3011163668",
          "1643817",
          "1000138054",
          "3010273872",
          "3002807850",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3044156918",
          "3003058448",
          "3008093809",
          "1000064530",
          "3004105270",
          "3001592626"
        ],
        "device_name": "Cardiac Ablation Percutaneous Catheter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}