PMA supplement
P210007 S005: Vivistim System
FDA PMA supplement · Normal 180 Day Track No User Fee · Mobia Medical, Inc.
Key facts
| Original PMA | P210007 |
|---|---|
| Supplement number | S005 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Vivistim System |
| Generic name | Stimulator, autonomic nerve, implanted for stroke rehabilitation |
| Applicant | Mobia Medical, Inc. |
| Product code | QPY |
| Received date | Mar 4, 2025 |
| Decision date | Apr 24, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: