{
  "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": "P150026",
      "supplement_number": "S014",
      "applicant": "Cardiofocus, Inc.",
      "street_1": "500 Nickerson Rd.",
      "street_2": "",
      "city": "Marlborough",
      "state": "MA",
      "zip": "01752",
      "zip_ext": "",
      "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
      "trade_name": "HeartLight Catheter, HeartLight X3 Console V2",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2022-04-22",
      "decision_date": "2023-02-24",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for changes to the Console of the HeartLight System.",
      "openfda": {
        "registration_number": [
          "3012693387",
          "3015544746",
          "3017060084",
          "3007029079",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "1721676",
          "3004063494",
          "3008093809",
          "3011120183",
          "1643817",
          "3005402529",
          "2028523",
          "3044156918",
          "9673241",
          "3001592626",
          "3017128979",
          "2124215",
          "2133810",
          "3000279201",
          "3007603855",
          "1650907",
          "1222616",
          "1000121056",
          "3008328679",
          "3004593495",
          "3002807314",
          "1225698",
          "3010273872",
          "3015537323",
          "3004859241",
          "3002648230",
          "3009243923",
          "3019807891",
          "2649622",
          "2024024",
          "3009504230",
          "3012520654",
          "3012263546",
          "3012260771",
          "3006891611",
          "3027305778",
          "9612164",
          "3004016520",
          "3012179728",
          "3016245399",
          "2182208",
          "1319639",
          "1721983",
          "3010705768",
          "3004105270",
          "2184149",
          "9617601",
          "9681260",
          "3013300026",
          "2032112",
          "9680001",
          "2032098",
          "9611665",
          "3012552532",
          "3013403214",
          "3015289131"
        ],
        "fei_number": [
          "3012693387",
          "3015544746",
          "3017060084",
          "3007029079",
          "3002534070",
          "1000120916",
          "3010653929",
          "3000203066",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "1721676",
          "3004063494",
          "3008093809",
          "3011120183",
          "1643817",
          "3005402529",
          "3044156918",
          "1000138054",
          "3003248396",
          "3001592626",
          "3017128979",
          "2124215",
          "3000279201",
          "3007603855",
          "3002681132",
          "1000121056",
          "3008328679",
          "3004593495",
          "3002807314",
          "3003076831",
          "3002807095",
          "3010273872",
          "3002808445",
          "3002648230",
          "3015537323",
          "3004859241",
          "3002806434",
          "3009243923",
          "3019807891",
          "1000064530",
          "2649622",
          "2024024",
          "3009504230",
          "3012520654",
          "3012263546",
          "3012260771",
          "3002806565",
          "3027305778",
          "1000125147",
          "1000139754",
          "3006891611",
          "3004016520",
          "3012179728",
          "3016245399",
          "2182208",
          "3010705768",
          "3001451473",
          "3013300026",
          "3003058448",
          "3004105270",
          "3012552532",
          "3013403214",
          "3015289131"
        ],
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}