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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceFlow FL-100
Generic NameCranial electrotherapy stimulator to treat depression
Regulation Number882.5800
ApplicantFlow Neuroscience AB
470 Ramona St.
Palo Alto, CA 94301
PMA NumberP230024
Date Received08/07/2023
Decision Date12/08/2025
Product Code JXK 
Advisory Committee Neurology
Clinical TrialsNCT05202119
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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