PMA
P190030: ActaStim-S Spine Fusion Stimulator
FDA PMA · Stimulator, bone growth, non-invasive · Theragen, Inc.
Key facts
| PMA number | P190030 |
|---|---|
| Trade name | ActaStim-S Spine Fusion Stimulator |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Theragen, Inc. |
| Owner/operator | Theragen Inc |
| Product code | LOF |
| Approval date | Dec 9, 2020 |
| Docket number | 20M-2288 |
| Notice date | Dec 16, 2020 |
| Establishment registration | 3013378804 |
| FEI number | 3013378804 |
At a glance
- 1–9 Supplements
- May 13, 2026 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- No Withdrawn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: