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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 NumberS004
Date Received05/09/2025
Decision Date06/05/2025
Product Code SAZ 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
changes in the ethylene oxide (EO) sterilization cycle parameters, including optimization of EO concentration, for the Nerve Cuff Electrode of the Altius System
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