Vivistim® System
FDA premarket approval P210007 · decided 2021-08-27
Approval details
- PMA number
- P210007
- Trade name
- Vivistim® System
- Generic name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- Applicant
- Mobia Medical, Inc.
- Date received
- 2021-03-02
- Decision date
- 2021-08-27
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- QPY
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Approval 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.
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