{
  "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": "P100010",
      "supplement_number": "S098",
      "applicant": "Medtronic Cryocath, LP",
      "street_1": "8200 Coral Sea St., Ms Mv S46",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
      "trade_name": "Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Panel Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2019-10-25",
      "decision_date": "2020-06-23",
      "docket_number": "20M-1613",
      "fed_reg_notice_date": "2020-07-31",
      "decision_code": "APPR",
      "ao_statement": "Approval for the Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than 6 months). The Freezor MAX Cardiac Cryoablation Catheter is used as an adjunctive device in the endocardial treatment of paroxysmal and persistent atrial fibrillation (episode duration less than 6 months) in conjunction with the Arctic Front Cryocatheter for the following uses:1)\tGap cryoablation to complete electrical isolation of the pulmonary veins;2\tCryoablation of focal trigger sites; and3)\tCreation of ablation line between the inferior vena cava and the tricuspid valve.",
      "openfda": {
        "registration_number": [
          "3012693387",
          "3015544746",
          "3017060084",
          "3007029079",
          "3010653929",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "1721676",
          "3004063494",
          "3008093809",
          "3011120183",
          "1643817",
          "3005402529",
          "2028523",
          "3044156918",
          "9673241",
          "3001592626",
          "3017128979",
          "2124215",
          "2133810",
          "3000279201",
          "3007603855",
          "1650907",
          "1222616",
          "1000121056",
          "3008328679",
          "3004593495",
          "3002807314",
          "1225698",
          "3010273872",
          "3015537323",
          "3004859241",
          "3002648230",
          "3009243923",
          "3019807891",
          "2649622",
          "2024024",
          "3009504230",
          "3012520654",
          "3012263546",
          "3012260771",
          "3006891611",
          "3027305778",
          "9612164",
          "3004016520",
          "3012179728",
          "3016245399",
          "2182208",
          "1319639",
          "1721983",
          "3010705768",
          "3004105270",
          "2184149",
          "9617601",
          "9681260",
          "3013300026",
          "2032112",
          "9680001",
          "2032098",
          "9611665",
          "3012552532",
          "3013403214",
          "3015289131"
        ],
        "fei_number": [
          "3012693387",
          "3015544746",
          "3017060084",
          "3007029079",
          "3002534070",
          "1000120916",
          "3010653929",
          "3000203066",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "1721676",
          "3004063494",
          "3008093809",
          "3011120183",
          "1643817",
          "3005402529",
          "3044156918",
          "1000138054",
          "3003248396",
          "3001592626",
          "3017128979",
          "2124215",
          "3000279201",
          "3007603855",
          "3002681132",
          "1000121056",
          "3008328679",
          "3004593495",
          "3002807314",
          "3003076831",
          "3002807095",
          "3010273872",
          "3002808445",
          "3002648230",
          "3015537323",
          "3004859241",
          "3002806434",
          "3009243923",
          "3019807891",
          "1000064530",
          "2649622",
          "2024024",
          "3009504230",
          "3012520654",
          "3012263546",
          "3012260771",
          "3002806565",
          "3027305778",
          "1000125147",
          "1000139754",
          "3006891611",
          "3004016520",
          "3012179728",
          "3016245399",
          "2182208",
          "3010705768",
          "3001451473",
          "3013300026",
          "3003058448",
          "3004105270",
          "3012552532",
          "3013403214",
          "3015289131"
        ],
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}