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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.
 
DeviceXstim Spine Fusion Stimulator
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantXstim, Inc.
1231 Greenway Dr.
Suite 260
Irving, TX 75038
PMA NumberP230025
Supplement NumberS001
Date Received08/14/2024
Decision Date11/12/2024
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a software change to extend the maximum total device activation time of the Xstim Spine Fusion Stimulator from 400 days to 1100 days.
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