MicroTransponder® Vivistim® Paired VNS™ System (Vivistim® System)

FDA Premarket Approval P210007 S001

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.

Pre-market Approval Supplement Details

Approval for updating the wireless transmitter from model 2000 to model 2100 to accommodate an obsolete part and accompanying changes to the software (saps model 4001) and implantable pulse generator (model 1001)

• Device: MicroTransponder® Vivistim® Paired VNS™ System (Vivistim® System)
• Generic Name: Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
• Applicant: MicroTransponder, Inc.
• Date Received: 2021-11-23
• Decision Date: 2022-02-16
• PMA: P210007
• Supplement: S001
• Product Code: QPY
• Advisory Committee: Physical Medicine
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: MicroTransponder, Inc. 2802 Flintrock Trace, Suite 226 austin, TX 78738

Supplemental Filings

Supplement Number	Date	Supplement Type
P210007		Original Filing
S001	2021-11-23	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
10810041430042	P210007	000
10810041430004	P210007	000
10810041430080	P210007	000
10810041430066	P210007	000
10810041430028	P210007	000
10810041430141	P210007	001