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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceProliv™Rx System
Generic NameCranial electrotherapy stimulator to treat depression
Regulation Number882.5800
ApplicantNeurolief , Ltd.
12 Giborei Israel St.
Netanya 42504
PMA NumberP250010
Date Received03/26/2025
Decision Date12/31/2025
Product Code JXK 
Advisory Committee Neurology
Clinical TrialsNCT02805881
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Proliv™Rx System provides focal external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS) treatment. It is intended as an adjunctive treatment for Major Depressive Disorder (MDD) in adults who failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in clinic. It is a prescription-only device.
Approval OrderApproval Order
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