PMA supplement
P970003 S246: VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103
FDA PMA supplement · Real-Time Process · LivaNova USA, Inc.
Key facts
| Original PMA | P970003 |
|---|---|
| Supplement number | S246 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103 |
| Generic name | Stimulator, autonomic nerve, implanted for epilepsy |
| Applicant | LivaNova USA, Inc. |
| Product code | LYJ |
| Received date | Dec 30, 2024 |
| Decision date | Mar 27, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: