{
  "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": "P240013",
      "supplement_number": "S014",
      "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": "HexaFlow™ Irrigation Pumo AFR-00004, HexaGen TM RF Generator AFR-00005, HexaPulse TM PF Generator AFR-00008",
      "product_code": "QZI",
      "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": "2025-06-26",
      "decision_date": "2025-07-23",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "the addition of new manufacturing tool (pump emulator) and associated manufacturing process at Medtronic Billerica manufacturing facility (Billerica, MA)",
      "openfda": {
        "registration_number": [
          "3012693387",
          "3017060084",
          "3007029079",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "3011120183",
          "9673241",
          "3001592626",
          "2124215",
          "2182269",
          "3009380063",
          "3000279201",
          "3007603855",
          "3005012805",
          "2183744",
          "1000121056",
          "3008328679",
          "3004593495",
          "3002807314",
          "3007648309",
          "3004859241",
          "3002648230",
          "3009243923",
          "9680579",
          "2024024",
          "3009504230",
          "3012520654",
          "3012263546",
          "3012260771",
          "3004016520",
          "3012179728",
          "3016245399",
          "2182208",
          "1319639",
          "1721983",
          "2184149",
          "9681260",
          "3013300026",
          "2032112",
          "3004105270",
          "3013403214",
          "9612164"
        ],
        "fei_number": [
          "3012693387",
          "3017060084",
          "3007029079",
          "3005334138",
          "3008452825",
          "1000203464",
          "1721686",
          "3008093809",
          "1928237",
          "3011120183",
          "1000138054",
          "3003248396",
          "3001592626",
          "2124215",
          "2182269",
          "3009380063",
          "3000279201",
          "3007603855",
          "3005012805",
          "2183744",
          "1000121056",
          "3008328679",
          "3004593495",
          "3002807314",
          "3003076831",
          "3007648309",
          "3004859241",
          "3002648230",
          "3002806434",
          "3009243923",
          "1000064530",
          "2024024",
          "3009504230",
          "3012520654",
          "3012263546",
          "3012260771",
          "3002806565",
          "1000139754",
          "3004016520",
          "3012179728",
          "3016245399",
          "2182208",
          "3013300026",
          "3004105270",
          "3013403214"
        ],
        "device_name": "Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}