PMA supplement
P830008 S003: CUTANIOUS GAS MONITOR
FDA PMA supplement · Sensor Medics Corp.
Key facts
| Original PMA | P830008 |
|---|---|
| Supplement number | S003 |
| Trade name | CUTANIOUS GAS MONITOR |
| Generic name | MONITOR, CARBON-DIOXIDE, CUTANEOUS |
| Applicant | Sensor Medics Corp. |
| Product code | LKD |
| Received date | Nov 6, 1984 |
| Decision date | Feb 29, 1988 |
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: