{
  "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": "S009",
      "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",
      "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": "2025-06-02",
      "decision_date": "2025-06-26",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "manufacturing software updates at the \"Final Catheter Inspection\" process to extend a conditioning process to one additional electrode and other minor updates",
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