{
  "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": "P920047",
      "supplement_number": "S133",
      "applicant": "Boston Scientific Corp",
      "street_1": "4100 Hamline Ave. N",
      "street_2": "",
      "city": "St Paul",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Cardiac ablation percutaneous catheter",
      "trade_name": "INTELLAGEN™ Cardiac Ablation System",
      "product_code": "LPB",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2023-07-14",
      "decision_date": "2024-07-17",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "an alternate and compatible radiofrequency (RF) generator, remote control, irrigation pump, tubing set, and foot pedal referred to collectively as the INTELLAGEN™ Cardiac Ablation System (INTELLAGEN)",
      "openfda": {
        "registration_number": [
          "3017060084",
          "3007695959",
          "3007029079",
          "3006634485",
          "3003084417",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "1643817",
          "2649622",
          "2028523",
          "3044156918",
          "9673241",
          "3001592626",
          "3003923762",
          "8020893",
          "2124215",
          "2182269",
          "1650907",
          "2135338",
          "1000121056",
          "2030404",
          "3010273872",
          "3015537323",
          "3004859241",
          "2029275",
          "3002648230",
          "1450662",
          "3009243923",
          "3019807891",
          "3012260771",
          "3006891611",
          "3001763079",
          "3012179728",
          "3010280625",
          "1313046",
          "1319639",
          "2182208",
          "3010705768",
          "1721983",
          "2184149",
          "9617601",
          "3004105270",
          "9681260",
          "3013300026",
          "2032112",
          "3011163668",
          "2648623",
          "9680001",
          "2032098",
          "9611665",
          "3012552532",
          "3013403214"
        ],
        "fei_number": [
          "3017060084",
          "3007695959",
          "3007029079",
          "3002534070",
          "3006634485",
          "3003084417",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "1643817",
          "2649622",
          "3044156918",
          "1000138054",
          "1000306431",
          "3003248396",
          "3001592626",
          "3003923762",
          "2124215",
          "2182269",
          "1000519796",
          "3002681132",
          "3005700659",
          "1000121056",
          "3003076831",
          "3002807095",
          "3010273872",
          "3002808445",
          "3002648230",
          "3015537323",
          "3004859241",
          "1450662",
          "3009243923",
          "3019807891",
          "3002807850",
          "1000064530",
          "3012260771",
          "3002806565",
          "3001763079",
          "1000125147",
          "1000139754",
          "3006891611",
          "3012179728",
          "3010280625",
          "1313046",
          "2182208",
          "3010705768",
          "3013300026",
          "3003058448",
          "3011163668",
          "2648623",
          "3004105270",
          "3012552532",
          "3013403214"
        ],
        "device_name": "Cardiac Ablation Percutaneous Catheter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}