PMA
P130022: NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
FDA PMA · Stimulator, spinal-cord, totally implanted for pain relief · Nevro Corporation
Key facts
| PMA number | P130022 |
|---|---|
| Trade name | NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Nevro Corporation |
| Owner/operator | Globus Medical, Inc |
| Product code | LGW |
| Approval date | May 8, 2015 |
| Docket number | 15M-1709 |
| Notice date | May 13, 2015 |
| Establishment registration | 3008514029 |
| FEI number | 3008514029 |
At a glance
- 10–99 Supplements
- Aug 18, 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- No Withdrawn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: