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Re: Arch_Investor post# 133551

Wednesday, 01/13/2021 11:01:54 AM

Wednesday, January 13, 2021 11:01:54 AM

Post# of 176828
60 calendar days

You can expect to receive a letter communicating the FDA's decision to grant or deny the Breakthrough Device designation request within 60 calendar days of the FDA receiving your request. It is helpful when a sponsor is available and responsive to the FDA's requests throughout the review timeline.Jan 5, 2021


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