PMA supplement
P890057 S003: MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT.
FDA PMA supplement · Panel Track · ZOLL Medical Corporation
Key facts
| Original PMA | P890057 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT. |
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Applicant | ZOLL Medical Corporation |
| Product code | LSZ |
| Received date | Jun 29, 1992 |
| Decision date | Sep 15, 1995 |
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: