{
  "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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      "applicant": "Biosense Webster, Inc.",
      "street_1": "31 Technology Dr., Suite 200",
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      "city": "Irvine",
      "state": "CA",
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      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2019-04-10",
      "decision_date": "2019-04-19",
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      "decision_code": "OK30",
      "ao_statement": "Add a semi-automated prep shaft machine as an alternate manufacturing process for the ThermoCool SmartTouch and ThermoCool SmartTouch SF catheters.",
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