{
  "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": "P030031",
      "supplement_number": "S146",
      "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 flutter",
      "trade_name": "EZ STEER THERMOCOOL NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHE",
      "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": "2026-08-18",
      "decision_date": "2026-09-15",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "an additional supplier for critical components",
      "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"
      }
    }
  ]
}