MicroTransponder Vivistim Paired VNS System
PMA P210007
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP210007 | Date27 Aug 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Vivistim® System
- Generic Name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- PMA Number
- FDA Product Code
- QPY
- Device Class
- Class III
- Advisory Committee
- Physical Medicine
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The MicroTransponder Vivistim Paired Vagus Nerve Stimulation (VNS) System is an implanted autonomic nerve stimulator designed for stroke rehabilitation. It delivers targeted electrical stimulation to the vagus nerve to mitigate upper extremity motor deficits and enhance motor function in chronic ischemic stroke patients with moderate to severe arm impairment.
This system is intended for use during rehabilitation therapy and is supplied as a paired, implanted device with FDA_PMA authorization under PMA number P210007. The components are reusable and intended for single-patient use, with no indication of MRI safety or sterility requirements specified in the regulatory data. The system is classified as a Class III device under the OpenFDA nomenclature.
Questions
AI-generated answers, 18 Sep 2026
What is the primary clinical purpose of the Vivistim® System, and how does it work?
The Vivistim® System is designed to stimulate the vagus nerve during stroke rehabilitation therapy. It delivers targeted electrical impulses to help reduce upper extremity motor deficits and improve motor function in patients with chronic ischemic stroke who have moderate to severe arm impairment. The device is intended to be used as part of a rehabilitation regimen to enhance recovery outcomes.
Is the Vivistim® System intended for single-use or reusable applications, and how is it supplied?
The Vivistim® System components are reusable but intended for single-patient use. This means the device can be used across multiple procedures for one patient but is not meant to be shared between different patients. The system is supplied as a paired, implanted device, specifically authorized for vagus nerve stimulation during rehabilitation therapy.
What regulatory pathway was followed for the approval of the Vivistim® System, and what classification does it hold?
The Vivistim® System received FDA approval through the Premarket Approval (PMA) pathway, with PMA number P210007. It is classified as a Class III medical device under the OpenFDA nomenclature, indicating it is subject to stringent regulatory oversight due to its intended use in stimulating autonomic nerves for therapeutic purposes.
Are there any specific storage requirements or considerations for the Vivistim® System?
The regulatory data for the Vivistim® System does not specify any explicit sterility requirements or storage conditions. However, since it is an implanted device intended for single-patient use, proper handling and storage in a clean, controlled environment are recommended to maintain its integrity and functionality before and after use.
What types of patients is the Vivistim® System intended to assist, and what conditions must they meet?
The Vivistim® System is intended for chronic ischemic stroke patients who have moderate to severe arm impairment and are undergoing rehabilitation therapy. It is specifically authorized to stimulate the vagus nerve to help mitigate upper extremity motor deficits and improve motor function in this patient population.