PMA supplement
P970003 S218: VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer
FDA PMA supplement · Real-Time Process · LivaNova USA, Inc.
Key facts
| Original PMA | P970003 |
|---|---|
| Supplement number | S218 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer |
| Generic name | Stimulator, autonomic nerve, implanted for epilepsy |
| Applicant | LivaNova USA, Inc. |
| Product code | LYJ |
| Received date | Apr 30, 2018 |
| Decision date | Jul 27, 2018 |
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: