{
  "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": "",
      "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/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2022-12-20",
      "decision_date": "2023-08-08",
      "docket_number": "23M-3943",
      "fed_reg_notice_date": "2023-09-15",
      "decision_code": "APPR",
      "ao_statement": "Approval for the Boston Scientific Cardiac Cryoablation System using the POLARx Cryoablation Balloon Catheters.  The device is indicated for the treatment of patients with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation (PAF). In addition it is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation. The SMARTFREEZE Cryo-Console is intended to be used with POLARx cryoablation balloon catheters only.",
      "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"
        ]
      }
    }
  ]
}