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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAltius® Direct Electrical Nerve Stimulation System
Generic Namestimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
ApplicantNeuros Medical, Inc.
26800 Aliso Viejo Parkway
Suite 250
Aliso Viejo, CA 92656
PMA NumberP230020
Date Received06/30/2023
Decision Date08/26/2024
Product Code SAZ 
Advisory Committee Neurology
Clinical TrialsNCT02221934
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval order for Altius® Direct Electrical Nerve Stimulation System. This device is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 
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