PMA
P840001: ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
FDA PMA · Stimulator, spinal-cord, totally implanted for pain relief · Medtronic Neuromodulation
Key facts
| PMA number | P840001 |
|---|---|
| Trade name | ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Medtronic Neuromodulation |
| Owner/operator | Medtronic, Inc. |
| Product code | LGW |
| Approval date | Nov 30, 1984 |
| Docket number | 84M-0415 |
| Notice date | Jan 2, 1985 |
| Establishment registration | 2182207 |
| FEI number | 2182207 |
At a glance
- 100–999 Supplements
- Oct 6, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: