{
  "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": "P240044",
      "supplement_number": "S004",
      "applicant": "Kardium, Inc.",
      "street_1": "8518 Glenlyon Pkwy.",
      "street_2": "Unit 155",
      "city": "Burnaby",
      "state": "",
      "zip": "V5J OB6",
      "zip_ext": "",
      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
      "trade_name": "Globe® Catheter; Globe® Pulsed Field System",
      "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": "2025-12-11",
      "decision_date": "2026-01-09",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "the automation of a process for removal of burrs and dross during rib manufacturing",
      "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"
        ]
      }
    }
  ]
}