{
  "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": "P220032",
      "supplement_number": "S005",
      "applicant": "Boston Scientific Corporation",
      "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 fibrillation",
      "trade_name": "POLARx™ Short Tip (ST) Cryoablation Balloon Catheter, POLARx™ Long Tip (LT) Cryoablation Balloon Catheter, POLARx™ FIT S",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2024-05-07",
      "decision_date": "2024-07-30",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "firmware updates to address issues with catheter recognition after connection to the SMARTFREEZE Console",
      "openfda": {
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3005402529",
          "3013403214",
          "2032112",
          "2124215",
          "9681260",
          "3012263546",
          "2182208",
          "1928237",
          "3000279201",
          "2649622",
          "9611665",
          "3012179728",
          "3011120183",
          "3017060084",
          "3009243923",
          "9680001",
          "3007029079",
          "9617601",
          "1721983",
          "3007603855",
          "3009504230",
          "3004016520",
          "2024024",
          "2032098",
          "3015537323",
          "3002648230",
          "3005334138",
          "3008452825",
          "3012520654",
          "1319639",
          "3019807891",
          "3027305778",
          "9673241",
          "3010653929",
          "1721686",
          "3016245399",
          "3004593495",
          "1650907",
          "3012260771",
          "3012693387",
          "3004063494",
          "3012552532",
          "3006891611",
          "9612164",
          "1643817",
          "1225698",
          "1721676",
          "3010273872",
          "1222616",
          "3015544746",
          "2133810",
          "2184149",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3044156918",
          "2028523",
          "3002807314",
          "3008093809",
          "3015289131",
          "3017128979",
          "3004105270",
          "3001592626",
          "3008328679"
        ],
        "fei_number": [
          "3005402529",
          "3013403214",
          "2182208",
          "2124215",
          "3012263546",
          "3002534070",
          "3002806565",
          "1928237",
          "3000279201",
          "2649622",
          "3004105270",
          "3002806434",
          "3012179728",
          "3011120183",
          "3017060084",
          "3009243923",
          "1000139754",
          "3007029079",
          "3007603855",
          "3009504230",
          "3004016520",
          "2024024",
          "3000203066",
          "3015537323",
          "3002648230",
          "3005334138",
          "3008452825",
          "3002808445",
          "3002807095",
          "1000125147",
          "3012520654",
          "3003076831",
          "3002681132",
          "3019807891",
          "3027305778",
          "3010653929",
          "1721686",
          "3016245399",
          "3004593495",
          "3012260771",
          "3012693387",
          "3004063494",
          "3012552532",
          "1000120916",
          "3006891611",
          "3003248396",
          "3001451473",
          "1643817",
          "1000138054",
          "1721676",
          "3010273872",
          "3015544746",
          "3004859241",
          "1000121056",
          "3010705768",
          "3013300026",
          "3044156918",
          "3002807314",
          "3008093809",
          "3003058448",
          "3015289131",
          "3017128979",
          "1000064530",
          "3001592626",
          "3008328679"
        ]
      }
    }
  ]
}