{
  "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",
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      "applicant": "Kardium, Inc.",
      "street_1": "8518 Glenlyon Pkwy.",
      "street_2": "Unit 155",
      "city": "Burnaby",
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      "zip": "V5J OB6",
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      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
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      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
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      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2025-12-08",
      "decision_date": "2026-01-06",
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      "decision_code": "OK30",
      "ao_statement": "a manufacturing change to replace a Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser welder with a fiber laser welder for producing the coupling subassembly at the distal end of the catheter shaft",
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