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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 NumberS010
Date Received01/20/2026
Decision Date01/28/2026
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  
MicroTransponder has revised the following material supplier information for the Vivistim Paired VNS System (P210007): Change #1: The supplier of the Model 3000 Implantable Lead Polyester Suture has introduced a new sub-supplier of the polyester fiber subcomponent of the sutures due to discontinuation of the raw material from the original sub-supplier.Change #2: The supplier of EPO-TEK-301 has introduced a new sub-supplier of a subcomponent (Part A) of the two-part EPO-TEK-301 epoxy due to discontinuation of the raw material from the original sub-supplier.
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