PMA
P210007: Vivistim® System
FDA PMA · Stimulator, autonomic nerve, implanted for stroke rehabilitation · Mobia Medical, Inc.
Key facts
| PMA number | P210007 |
|---|---|
| Trade name | Vivistim® System |
| Generic name | Stimulator, autonomic nerve, implanted for stroke rehabilitation |
| Applicant | Mobia Medical, Inc. |
| Owner/operator | Mobia Medical Inc. |
| Product code | QPY |
| Approval date | Aug 27, 2021 |
| Docket number | 21M-0991 |
| Notice date | Sep 10, 2021 |
| Establishment registration | 3012309950 |
| FEI number | 3012309950 |
At a glance
- 10–99 Supplements
- Sep 16, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: