{
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-12",
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      "street_1": "4100 Hamline Ave. N",
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      "state": "MN",
      "zip": "55112",
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      "supplement_type": "135 Review Track For 30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
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      "date_received": "2018-10-25",
      "decision_date": "2019-01-09",
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      "decision_code": "APPR",
      "ao_statement": "Approval of manufacturing changes, specifically, the addition of BSC Heredia as an alternate supplier for the Steering Control Wire Subassembly.",
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