{
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    "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/",
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      "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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      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2022-09-02",
      "decision_date": "2022-09-30",
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      "decision_code": "OK30",
      "ao_statement": "Add an additional chamber for the sterilization of catheters and cables at the Isomedix Operation, Inc. (Steris Grand Prairie) facility in Grand Prairie, Texas.",
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