PMA
P890034: MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR
FDA PMA · VENTILATOR, HIGH FREQUENCY · Covidien
Key facts
| PMA number | P890034 |
|---|---|
| Trade name | MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR |
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Applicant | Covidien |
| Owner/operator | Covidien llc |
| Product code | LSZ |
| Approval date | Dec 13, 1991 |
| Docket number | 91M-0508 |
| Establishment registration | 1282497 |
| FEI number | 1282497 |
At a glance
- 1–9 Supplements
- Jun 24, 1997 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: