{
  "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": "P150005",
      "supplement_number": "S086",
      "applicant": "Boston Scientific Corp",
      "street_1": "4100 Hamline Ave. N",
      "street_2": "",
      "city": "St Paul",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
      "trade_name": "Blazer Open Irrigated Ablation Catheter, IntellaNav Open Irrigated Ablation Catheter, IntellaNav MiFi Open Irrigated Abl",
      "product_code": "OAD",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2024-08-16",
      "decision_date": "2024-11-14",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for a change in the adhesive used in the proximal extension tube to female luer lock adhesive joint, a new product specification, and modifications to manufacturing processes",
      "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"
      }
    }
  ]
}