{
  "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": "P110016",
      "supplement_number": "S093",
      "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 (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE)",
      "product_code": "OAD",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2026-03-27",
      "decision_date": "2026-04-09",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "an alternative supplier for the Flex Tip subassembly (Flex Tip)",
      "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"
      }
    }
  ]
}