{
  "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": "S111",
      "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": "Artic Front Advance and Artic Front Advance Pro Cryoablation Catheter",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2020-11-19",
      "decision_date": "2020-12-15",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "to implement two alternate manufacturing Cell Operating System (COS) stations and to update associated equipment and inspection procedures",
      "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"
      }
    }
  ]
}