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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 System
Generic NameStimulator, autonomic nerve, implanted for stroke rehabilitation
ApplicantMobia Medical, Inc.
2802 Flintrock Trace, Suite 226
Austin, TX 78738
PMA NumberP210007
Supplement NumberS005
Date Received03/04/2025
Decision Date04/24/2025
Product Code QPY 
Advisory Committee Physical Medicine
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Site Change Supplement located at the MN Ops Center, 5155 E. River Rd., Suite 409, Fridley, MN, 55421 for receiving, storage, and shipping of the Vivistim System.
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