{
  "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": "P110016",
      "supplement_number": "S082",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "2375 Morse Ave.",
      "street_2": "",
      "city": "Plymouth",
      "state": "MN",
      "zip": "55442",
      "zip_ext": "",
      "generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
      "trade_name": "FlexAbility™ Ablation Catheter, Sensor Enabled™",
      "product_code": "OAD",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Postapproval Study Protocol",
      "expedited_review_flag": "N",
      "date_received": "2023-01-17",
      "decision_date": "2023-02-24",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval of the protocol for the Abbott Ventricular Tachycardia Post Approval Study.",
      "openfda": {
        "registration_number": [
          "3017060084",
          "3007695959",
          "3007029079",
          "3006634485",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "1643817",
          "3011120183",
          "2028523",
          "9673241",
          "3001592626",
          "2124215",
          "2182269",
          "3000279201",
          "3010291427",
          "1650907",
          "1000121056",
          "3008328679",
          "3002807314",
          "2030404",
          "3010273872",
          "3015537323",
          "3004859241",
          "1721504",
          "3009243923",
          "3019807891",
          "3013581838",
          "3012520654",
          "3012260771",
          "3001763079",
          "3004016520",
          "3012179728",
          "3016245399",
          "3010280625",
          "2182208",
          "1319639",
          "1721983",
          "3010705768",
          "3004105270",
          "2184149",
          "9681260",
          "3013300026",
          "2032112",
          "9680001",
          "2032098",
          "3012552532",
          "3013403214",
          "9612164"
        ],
        "fei_number": [
          "3017060084",
          "3007695959",
          "3007029079",
          "3006634485",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "1643817",
          "3011120183",
          "1000138054",
          "3003248396",
          "3001592626",
          "2124215",
          "2182269",
          "1000519796",
          "3000279201",
          "3010291427",
          "3002681132",
          "1000121056",
          "3008328679",
          "3002807314",
          "3003076831",
          "3010273872",
          "3002808445",
          "3015537323",
          "3004859241",
          "3002806434",
          "1721504",
          "3009243923",
          "3019807891",
          "1000064530",
          "3013581838",
          "3012520654",
          "3012260771",
          "3002806565",
          "3001763079",
          "1000125147",
          "1000139754",
          "3004016520",
          "3012179728",
          "3016245399",
          "3010280625",
          "2182208",
          "3010705768",
          "3013300026",
          "3003058448",
          "3004105270",
          "3012552532",
          "3013403214"
        ],
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}