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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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 Pkwy.
Suite 250
Aliso Viejo, CA 92656
PMA NumberP230020
Supplement NumberS006
Date Received11/25/2025
Decision Date05/05/2026
Product Code SAZ 
Advisory Committee Neurology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the addition of an alternate test method (Bacterial Endotoxin Testing Chromogenic) for endotoxin testing of the Implantable Pulse Generator (IPG) and IPG Accessory Kit components of the Altius System and a change in the test lab supplier for endotoxin testing from Integer Uruguay to Labcorp and Integer Plymouth.
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