{
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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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    "last_updated": "2026-10-12",
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      "trade_name": "IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable",
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      "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2021-03-11",
      "decision_date": "2021-04-08",
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      "decision_code": "APPR",
      "ao_statement": "Approval for a manufacturing site located at Boston Scientific Corporation, 4100 Hamline Avenue North, Saint Paul, Minnesota, for the manufacturing, distribution, and warehousing activities for the IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable.",
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