PMA
P130028: ALGOVITA SPINAL CORD STIMULATION SYSTEM
FDA PMA · Stimulator, spinal-cord, totally implanted for pain relief · Nuvectra Corporation
Key facts
| PMA number | P130028 |
|---|---|
| Trade name | ALGOVITA SPINAL CORD STIMULATION SYSTEM |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Nuvectra Corporation |
| Product code | LGW |
| Approval date | Nov 20, 2015 |
| Docket number | 15M-4434 |
| Notice date | Nov 30, 2015 |
| FEI number | 3011874692 |
At a glance
- 10–99 Supplements
- May 5, 2020 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- No Withdrawn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: