{
  "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": "P240013",
      "supplement_number": "S025",
      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
      "trade_name": "Sphere-9 Catheter and Affera Ablation System",
      "product_code": "QZI",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2026-04-02",
      "decision_date": "2026-05-15",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "a new contract manufacturer, a new sterilization site, and a new packaging configuration and material (along with suppliers) for Catheter Extension Cable (Model AFR 00006)",
      "openfda": {
        "device_name": "Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3013403214",
          "2032112",
          "2124215",
          "9681260",
          "3012263546",
          "2182208",
          "1928237",
          "3009380063",
          "3000279201",
          "2182269",
          "3012179728",
          "3011120183",
          "3017060084",
          "3009243923",
          "3007648309",
          "3007029079",
          "1721983",
          "3007603855",
          "3009504230",
          "3004016520",
          "3005012805",
          "2024024",
          "3002648230",
          "3005334138",
          "3008452825",
          "2183744",
          "3012520654",
          "1319639",
          "9680579",
          "9673241",
          "1721686",
          "3016245399",
          "3004593495",
          "3012260771",
          "3012693387",
          "9612164",
          "2184149",
          "3004859241",
          "1000121056",
          "3013300026",
          "3002807314",
          "3008093809",
          "3004105270",
          "3001592626",
          "3008328679"
        ],
        "fei_number": [
          "3013403214",
          "2182208",
          "2124215",
          "3012263546",
          "3000279201",
          "3002806565",
          "3009380063",
          "1928237",
          "2182269",
          "1000203464",
          "3002806434",
          "3012179728",
          "3011120183",
          "3017060084",
          "3009243923",
          "1000139754",
          "3007648309",
          "3007029079",
          "3007603855",
          "3009504230",
          "3004016520",
          "3005012805",
          "2024024",
          "3002648230",
          "3005334138",
          "3008452825",
          "2183744",
          "3012520654",
          "3003076831",
          "1721686",
          "3016245399",
          "3004593495",
          "3012260771",
          "3012693387",
          "3003248396",
          "1000138054",
          "3004859241",
          "1000121056",
          "3013300026",
          "3002807314",
          "3008093809",
          "1000064530",
          "3004105270",
          "3001592626",
          "3008328679"
        ]
      }
    }
  ]
}