{
  "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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      "supplement_number": "S076",
      "applicant": "Biosense Webster, Inc.",
      "street_1": "31 Technology Dr., Suite 200",
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      "city": "Irvine",
      "state": "CA",
      "zip": "92618",
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      "generic_name": "Cardiac ablation percutaneous catheter",
      "trade_name": "ThermoCool SmartTouch SF Catheters",
      "product_code": "LPB",
      "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": "2021-01-07",
      "decision_date": "2021-01-22",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "Transfer the extrusion process for the Quad Lumen Core subcomponent from the Biosense Webster Inc. Irwindale, CA facility to the Biosense Webster, Inc. Juarez, MX facility.",
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