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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 Pair VNS System
Generic NameStimulator, autonomic nerve, implanted for stroke rehabilitation
ApplicantMobia Medical, Inc.
2802 Flintrock Trace, Suite 226
Austin, TX 78738
PMA NumberP210007
Supplement NumberS014
Date Received05/22/2026
Decision Date06/18/2026
Product Code QPY 
Advisory Committee Physical Medicine
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  
Approval for supplier change
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