{
  "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": "S131",
      "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 Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "135 Review Track For 30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2022-10-14",
      "decision_date": "2023-04-27",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for implementing a parametric release method at Steri-Tech in Salinas, Puerto Rico.",
      "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"
      }
    }
  ]
}