{
  "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": "P210027",
      "supplement_number": "",
      "applicant": "Biosense Webster, Inc.",
      "street_1": "31 Technology Dr., Suite 200",
      "street_2": "",
      "city": "Irvine",
      "state": "CA",
      "zip": "92618",
      "zip_ext": "",
      "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
      "trade_name": "QDOT MICRO™ System",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2021-07-06",
      "decision_date": "2022-11-23",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the Biosense Webster QDOT MICRO Catheter and related accessory devices. The device is indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF generator, for the treatment of:1)\tType I atrial flutter in patients age 18 or older; and2)\tDrug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The QDOT MICRO Catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO® 3 Navigation System.",
      "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"
        ]
      }
    }
  ]
}