PMA supplement
P890057 S021: 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
FDA PMA supplement · 30-Day Notice · ZOLL Medical Corporation
Key facts
| Original PMA | P890057 |
|---|---|
| Supplement number | S021 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV) |
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Applicant | ZOLL Medical Corporation |
| Product code | LSZ |
| Received date | Oct 28, 2013 |
| Decision date | Nov 22, 2013 |
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: