PMA supplement
P970003 S169: VNS THERAPY GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC)
FDA PMA supplement · Real-Time Process · LivaNova USA, Inc.
Key facts
| Original PMA | P970003 |
|---|---|
| Supplement number | S169 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | VNS THERAPY GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC) |
| Generic name | Stimulator, autonomic nerve, implanted (depression) |
| Applicant | LivaNova USA, Inc. |
| Product code | MUZ |
| Received date | Apr 4, 2014 |
| Decision date | Jul 2, 2014 |
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: