{
  "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",
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      "street_1": "3715 Haven Ave.",
      "street_2": "Suite 110",
      "city": "Menlo Park",
      "state": "CA",
      "zip": "94025",
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      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2024-09-24",
      "decision_date": "2024-10-24",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "updates to the catheter shaft manufacturing process for the FARAWAVE Pulsed Field Ablation (PFA) Catheter",
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