PMA
P970003: VNS THERAPY SYSTEM
FDA PMA · Stimulator, autonomic nerve, implanted for epilepsy · LivaNova USA, Inc.
Key facts
| PMA number | P970003 |
|---|---|
| Trade name | VNS THERAPY SYSTEM |
| Generic name | Stimulator, autonomic nerve, implanted for epilepsy |
| Applicant | LivaNova USA, Inc. |
| Owner/operator | LivaNova USA, Inc. |
| Product code | LYJ |
| Approval date | Jul 16, 1997 |
| Docket number | 98M-0140 |
| Notice date | Mar 4, 1998 |
| Establishment registration | 1644487 |
| FEI number | 1000117004 |
At a glance
- 100–999 Supplements
- Oct 2, 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- No Withdrawn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: