{
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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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      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2022-11-14",
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      "decision_code": "OK30",
      "ao_statement": "Alternate tier 3 supplier of resin for the FlexAbility/FlexAbility SE Ablation Catheters, TactiCath SE Ablation Catheter, Livewire TC Ablation Catheter, and Safire Ablation Catheter.",
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