{
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    "terms": "https://open.fda.gov/terms/",
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      "ao_statement": "approval for the Connection Interface Unit (CIU) to be used with the TRUPULSE Generator, to introduce a predetermined change control plan (PCCP) (Predetermined Change Control Plan TRUPULSE Generator System Version 1.0) for planned hardware and software changes to the TRUPULSE Generator and related labeling updates",
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