{
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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",
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      "trade_name": "SmartAblate™ Irrigation Tubing Set",
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      "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2022-06-24",
      "decision_date": "2023-01-24",
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      "decision_code": "APPR",
      "ao_statement": "Approval for alternate components; changes in sterilization monitoring; an alternate physical manufacturing site at Harmac Medical Products, Inc. H3 de Tijuana S. de RL de CV Calle Maquiladoras No. 320-A Col. Ciudad Industrial Nueva Tijuana CP 22500 Mexico; and an alternate sterilization site at STERIS AST, 1000 Sarah Place, Ontario, CA 91761 USA.",
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