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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 NumberS001
Date Received11/25/2024
Decision Date12/19/2024
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  
the replacement of a sub-component of EPO-TEK® 301 epoxy, known as Part A, with an equivalent material sourced from a different supplier
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