PMA
P880013: INFANT STAR HIGH FREQUENCY VENTILATOR
FDA PMA · VENTILATOR, HIGH FREQUENCY · Nellcor Puritan Bennett, Inc.
Key facts
| PMA number | P880013 |
|---|---|
| Trade name | INFANT STAR HIGH FREQUENCY VENTILATOR |
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Applicant | Nellcor Puritan Bennett, Inc. |
| Product code | LSZ |
| Approval date | Jan 19, 1990 |
| Docket number | 90M-0069 |
| Notice date | Mar 16, 1990 |
| FEI number | 3002658105 |
At a glance
- 1–9 Supplements
- Dec 17, 2002 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: