PMA supplement
P190021 S003: Reactiv8 Implantable Neurostimulation System
FDA PMA supplement · 135 Review Track For 30-Day Notice · Mainstay Medical Limited
Key facts
| Original PMA | P190021 |
|---|---|
| Supplement number | S003 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Reactiv8 Implantable Neurostimulation System |
| Generic name | Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief |
| Applicant | Mainstay Medical Limited |
| Product code | QLK |
| Received date | Jan 13, 2023 |
| Decision date | Jun 23, 2023 |
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: