PMA supplement
P890057 S014: MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
FDA PMA supplement · Panel Track · ZOLL Medical Corporation
Key facts
| Original PMA | P890057 |
|---|---|
| Supplement number | S014 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV) |
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Applicant | ZOLL Medical Corporation |
| Product code | LSZ |
| Received date | Feb 22, 2001 |
| Decision date | Sep 24, 2001 |
| Docket number | 01M-0520 |
| Notice date | Nov 19, 2001 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: