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.
| Device | Vivistim® System |
| Generic Name | Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation |
| Applicant | MicroTransponder, Inc. |
| Date Received | 2021-03-02 |
| Decision Date | 2021-08-27 |
| PMA | P210007 |
| Supplement | S |
| Product Code | QPY |
| Advisory Committee | Physical Medicine |
| 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