PMA
P230020: Altius® Direct Electrical Nerve Stimulation System
FDA PMA · Stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb · Neuros Medical, Inc.
Key facts
| PMA number | P230020 |
|---|---|
| Trade name | Altius® Direct Electrical Nerve Stimulation System |
| Generic name | Stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb |
| Applicant | Neuros Medical, Inc. |
| Owner/operator | Neuros Medical Inc. |
| Product code | SAZ |
| Approval date | Aug 26, 2024 |
| Establishment registration | 3026283936 |
| FEI number | 3026283936 |
At a glance
- 1–9 Supplements
- May 5, 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- No Withdrawn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: