Vivistim® System

FDA Premarket Approval P210007

Pre-market Approval Supplement Details

Approval order for 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.

DeviceVivistim® System
Generic NameStimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
ApplicantMicroTransponder, Inc.
Date Received2021-03-02
Decision Date2021-08-27
PMAP210007
SupplementS
Product CodeQPY 
Advisory CommitteePhysical Medicine
Expedited ReviewNo
Combination Product No
Applicant Address MicroTransponder, Inc. 2802 Flintrock Trace, Suite 226 austin, TX 78738

Supplemental Filings

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Supplement NumberDateSupplement Type
P210007Original Filing

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