PMA supplement
P970003 S197: Pulse, PulseDuo, DemiPulse, DemiPulseDuo, AspireHC, Aspire SR Generators.
FDA PMA supplement · Normal 180 Day Track · LivaNova USA, Inc.
Key facts
| Original PMA | P970003 |
|---|---|
| Supplement number | S197 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Pulse, PulseDuo, DemiPulse, DemiPulseDuo, AspireHC, Aspire SR Generators. |
| Generic name | Stimulator, autonomic nerve, implanted for epilepsy |
| Applicant | LivaNova USA, Inc. |
| Product code | LYJ |
| Received date | May 3, 2016 |
| Decision date | Jul 28, 2016 |
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: