PMA supplement
P890057 S028: 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator
FDA PMA supplement · 135 Review Track For 30-Day Notice · ZOLL Medical Corporation
Key facts
| Original PMA | P890057 |
|---|---|
| Supplement number | S028 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator |
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Applicant | ZOLL Medical Corporation |
| Product code | LSZ |
| Received date | Jul 3, 2023 |
| Decision date | Feb 20, 2024 |
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: