PMA supplement
P800003 S001: MODEL 9310 LUNG WATER COMPUTER
FDA PMA supplement · Edwards Lifesciences, LLC
Key facts
| Original PMA | P800003 |
|---|---|
| Supplement number | S001 |
| Trade name | MODEL 9310 LUNG WATER COMPUTER |
| Generic name | MONITOR, LUNG WATER MEASUREMENT |
| Applicant | Edwards Lifesciences, LLC |
| Product code | JEZ |
| Received date | Mar 17, 1981 |
| Decision date | Jun 12, 1981 |
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: