{
  "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": "P060019",
      "supplement_number": "S059",
      "applicant": "Irvine Biomedical, Inc.",
      "street_1": "2375 Morse Ave.",
      "street_2": "",
      "city": "Irvine",
      "state": "CA",
      "zip": "92614",
      "zip_ext": "",
      "generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
      "trade_name": "Ampere Generator",
      "product_code": "OAD",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2026-05-11",
      "decision_date": "2026-08-07",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for firmware changes to the TactiSys Quartz Equipment v1.8.0 and Ampere Generator v1.2.0 to maintain compatibility with the TactiFlex Duo Ablation Catheter, Sensor Enabled",
      "openfda": {
        "registration_number": [
          "3013403214",
          "2032112",
          "2124215",
          "9681260",
          "2182208",
          "3000279201",
          "3007695959",
          "1928237",
          "2182269",
          "3012179728",
          "3011120183",
          "3010280625",
          "3009243923",
          "3017060084",
          "3001763079",
          "9680001",
          "3007029079",
          "1721983",
          "3004016520",
          "2032098",
          "2030404",
          "3015537323",
          "1721504",
          "3010291427",
          "3005334138",
          "3008452825",
          "3012520654",
          "3006634485",
          "1319639",
          "3019807891",
          "9673241",
          "3010653929",
          "1721686",
          "3016245399",
          "1650907",
          "3012260771",
          "3012552532",
          "9612164",
          "1643817",
          "3010273872",
          "2184149",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3013581838",
          "2028523",
          "3002807314",
          "3008093809",
          "3004105270",
          "3001592626",
          "3008328679"
        ],
        "fei_number": [
          "3013403214",
          "2182208",
          "2124215",
          "3000279201",
          "3007695959",
          "3002806565",
          "1928237",
          "2182269",
          "3002806434",
          "3012179728",
          "3011120183",
          "3010280625",
          "3009243923",
          "3017060084",
          "1000139754",
          "3001763079",
          "3007029079",
          "3004016520",
          "1000519796",
          "3015537323",
          "1721504",
          "3010291427",
          "3005334138",
          "3008452825",
          "3002808445",
          "1000125147",
          "3012520654",
          "3006634485",
          "3003076831",
          "3002681132",
          "3019807891",
          "3010653929",
          "1721686",
          "3016245399",
          "3012260771",
          "3012552532",
          "3003248396",
          "1643817",
          "1000138054",
          "3010273872",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3013581838",
          "3002807314",
          "3008093809",
          "3003058448",
          "1000064530",
          "3004105270",
          "3001592626",
          "3008328679"
        ],
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}