{
  "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": "P130026",
      "supplement_number": "S101",
      "applicant": "St Jude Medical",
      "street_1": "One St. Jude Medical Dr.",
      "street_2": "",
      "city": "St. Paul",
      "state": "MN",
      "zip": "55117",
      "zip_ext": "",
      "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
      "trade_name": "TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE)",
      "product_code": "OAE",
      "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": "2026-05-01",
      "decision_date": "2026-05-29",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "the addition of a secondary supplier for the fluid lumen component and a change to the luer hub mold tool",
      "openfda": {
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3005402529",
          "3013403214",
          "2032112",
          "2124215",
          "9681260",
          "3012263546",
          "2182208",
          "1928237",
          "3000279201",
          "2649622",
          "9611665",
          "3012179728",
          "3011120183",
          "3017060084",
          "3009243923",
          "9680001",
          "3007029079",
          "9617601",
          "1721983",
          "3007603855",
          "3009504230",
          "3004016520",
          "2024024",
          "2032098",
          "3015537323",
          "3002648230",
          "3005334138",
          "3008452825",
          "3012520654",
          "1319639",
          "3019807891",
          "3027305778",
          "9673241",
          "3010653929",
          "1721686",
          "3016245399",
          "3004593495",
          "1650907",
          "3012260771",
          "3012693387",
          "3004063494",
          "3012552532",
          "3006891611",
          "9612164",
          "1643817",
          "1225698",
          "1721676",
          "3010273872",
          "1222616",
          "3015544746",
          "2133810",
          "2184149",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3044156918",
          "2028523",
          "3002807314",
          "3008093809",
          "3015289131",
          "3017128979",
          "3004105270",
          "3001592626",
          "3008328679"
        ],
        "fei_number": [
          "3005402529",
          "3013403214",
          "2182208",
          "2124215",
          "3012263546",
          "3002534070",
          "3002806565",
          "1928237",
          "3000279201",
          "2649622",
          "3004105270",
          "3002806434",
          "3012179728",
          "3011120183",
          "3017060084",
          "3009243923",
          "1000139754",
          "3007029079",
          "3007603855",
          "3009504230",
          "3004016520",
          "2024024",
          "3000203066",
          "3015537323",
          "3002648230",
          "3005334138",
          "3008452825",
          "3002808445",
          "3002807095",
          "1000125147",
          "3012520654",
          "3003076831",
          "3002681132",
          "3019807891",
          "3027305778",
          "3010653929",
          "1721686",
          "3016245399",
          "3004593495",
          "3012260771",
          "3012693387",
          "3004063494",
          "3012552532",
          "1000120916",
          "3006891611",
          "3003248396",
          "3001451473",
          "1643817",
          "1000138054",
          "1721676",
          "3010273872",
          "3015544746",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3044156918",
          "3002807314",
          "3008093809",
          "3003058448",
          "3015289131",
          "3017128979",
          "1000064530",
          "3001592626",
          "3008328679"
        ]
      }
    }
  ]
}