PMA
P150004: Axium Neurostimulator System
FDA PMA · Dorsal root ganglion stimulator for pain relief · ABBOTT MEDICAL
Key facts
| PMA number | P150004 |
|---|---|
| Trade name | Axium Neurostimulator System |
| Generic name | Dorsal root ganglion stimulator for pain relief |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | PMP |
| Approval date | Feb 11, 2016 |
| Docket number | 16M-0804 |
| Notice date | Mar 7, 2016 |
| Establishment registration | 1627487 |
| FEI number | 1627487 |
At a glance
- 10–99 Supplements
- Sep 23, 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- No Withdrawn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: