{
  "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": "P130026",
      "supplement_number": "S078",
      "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": "TactiSys™ Quartz Equipment",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2022-01-27",
      "decision_date": "2022-04-27",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the TactiSys Quartz Equipment SW v1.7.2 software maintenance release to disable the charging of a non-rechargeable Real Time Clock (RTC) battery.",
      "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"
      }
    }
  ]
}