Flow FL-100
FDA premarket approval P230024 · decided 2025-12-08
Approval details
- PMA number
- P230024
- Trade name
- Flow FL-100
- Generic name
- Cranial electrotherapy stimulator to treat depression
- Applicant
- Flow Neuroscience AB
- Date received
- 2023-08-07
- Decision date
- 2025-12-08
- Days to decision
- 854 days
- Decision code
- APPR
- Product code
- JXK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Palo Alto, CA
- 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.
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