PMA
P800003: MODEL 9310 LUNG WATER COMPUTER
FDA PMA · MONITOR, LUNG WATER MEASUREMENT · Edwards Lifesciences, LLC
Key facts
| PMA number | P800003 |
|---|---|
| Trade name | MODEL 9310 LUNG WATER COMPUTER |
| Generic name | MONITOR, LUNG WATER MEASUREMENT |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | JEZ |
| Approval date | Jul 28, 1980 |
| Docket number | 80M-0317 |
| Notice date | Sep 12, 1980 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- 1–9 Supplements
- Jun 12, 1981 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- Yes Withdrawn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: