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Post# of 177065
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Sunday, 06/30/2024 9:57:28 PM

Sunday, June 30, 2024 9:57:28 PM

Post# of 177065
From thr FDA: "An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved."
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