{
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-05",
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      "street_1": "4100 Hamline Ave. N",
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      "state": "MN",
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      "trade_name": "ACUITY X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY X4 Flushing Tool/Wire Guide (Model 4604)",
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      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
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      "date_received": "2026-04-17",
      "decision_date": "2026-05-15",
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      "decision_code": "OK30",
      "ao_statement": "to change sites for ethylene oxide (EO) gas sterilization operations and final packaging activities for the Accessories used with the Cardiac Rhythm Management (CRM) divisions Pulse Generators and Leads.",
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