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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceVivistim® System
Generic NameStimulator, autonomic nerve, implanted for stroke rehabilitation
ApplicantMicroTransponder, Inc.
2802 Flintrock Trace, Suite 226
Austin, TX 78738
PMA NumberP210007
Date Received03/02/2021
Decision Date08/27/2021
Product Code QPY 
Docket Number 21M-0991
Notice Date 09/10/2021
Advisory Committee Physical Medicine
Clinical TrialsNCT03131960
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval the MicroTransponder® Vivistim® Paired VNS System (Vivistim ® System) is intended to be used to stimulate the vagus nerve during rehabilitation therapy in order to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002