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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.
 
DeviceMicroTransponder Vivistim Paired VNS System (Vivistim System)
Generic NameStimulator, autonomic nerve, implanted for stroke rehabilitation
ApplicantMobia Medical, Inc.
2802 Flintrock Trace, Suite 226
Austin, TX 78738
PMA NumberP210007
Supplement NumberS003
Date Received06/06/2024
Decision Date08/21/2024
Product Code QPY 
Advisory Committee Physical Medicine
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  
Your supplement requested approval for changes to the device software to fix several bugs, incorporate patient and clinician feedback, and strengthen the password requirements of the device login.
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