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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.
 
DeviceVivistim® Paired VNS System
Generic NameStimulator, autonomic nerve, implanted for stroke rehabilitation
ApplicantMobia Medical, Inc.
2802 Flintrock Trace, Suite 226
Austin, TX 78738
PMA NumberP210007
Supplement NumberS008
Date Received11/26/2025
Decision Date02/26/2026
Product Code QPY 
Advisory Committee Physical Medicine
Clinical TrialsNCT03131960
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expansion of MN Ops Center capabilities, including component receiving inspection & acceptance, in-house manufacturing and software installation of Stroke Application & Programming software (SAPS), routine software/firmware upgrades, and device relabeling.
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