PMA
P800068: ENDOTRACHEAL TUBE CHANGER
FDA PMA · Changer, tube, endotracheal · Instrumentation Industries, Inc.
Key facts
| PMA number | P800068 |
|---|---|
| Trade name | ENDOTRACHEAL TUBE CHANGER |
| Generic name | Changer, tube, endotracheal |
| Applicant | Instrumentation Industries, Inc. |
| Owner/operator | INSTRUMENTATION INDUSTRIES, INCORPORATED |
| Product code | LNZ |
| Approval date | Jul 21, 1981 |
| Notice date | Aug 14, 1981 |
| Establishment registration | 2518436 |
| FEI number | 2518436 |
At a glance
- 1–9 Supplements
- Nov 4, 1999 Latest supplement decision
- No Withdrawn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: