{
  "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": {
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      "supplement_number": "S012",
      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
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      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
      "trade_name": "Sphere-9 Catheter and Affera Ablation System (HexaFlow™ Irrigation Pump; HexaGen™ RF Generator; HexaPulse™ PF Generator)",
      "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": "2025-06-23",
      "decision_date": "2025-07-22",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "the automation of certain electrical safety tests and an update to an associated manufacturing process for the HexaFlow Irrigation Pump, HexaGen RF Generator, and HexaPulse PF Generator",
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