PMA
P190021: ReActiv8 Implantable Neurostimulation System
FDA PMA · Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief · Mainstay Medical Limited
Key facts
| PMA number | P190021 |
|---|---|
| Trade name | ReActiv8 Implantable Neurostimulation System |
| Generic name | Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief |
| Applicant | Mainstay Medical Limited |
| Owner/operator | Mainstay Medical Limited |
| Product code | QLK |
| Approval date | Jun 16, 2020 |
| Docket number | 20M-1583 |
| Notice date | Jun 22, 2020 |
| Establishment registration | 3021520203 |
| FEI number | 3021520203 |
At a glance
- 1–9 Supplements
- Jun 20, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: