{
  "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": "S003",
      "applicant": "Farapulse, Inc.",
      "street_1": "3715 Haven Ave.",
      "street_2": "Suite 110",
      "city": "Menlo Park",
      "state": "CA",
      "zip": "94025",
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      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
      "trade_name": "FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation Catheter, FARASTAR™ Pulsed Field Ablation",
      "product_code": "QZI",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2024-04-05",
      "decision_date": "2024-10-18",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for new and updated components of the FARAPULSE™ Pulsed Field Ablation (PFA) System, including the FARAWAVE Catheter, FARASTAR Mapping System Module, FARASTAR Generator, and FARASTAR Recording System Module",
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