PMA supplement
P810037 S007: KONTRON CUTANEOUS PCO2 MONITOR
FDA PMA supplement · Normal 180 Day Track · Kontron Cardiovascular
Key facts
| Original PMA | P810037 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | KONTRON CUTANEOUS PCO2 MONITOR |
| Generic name | MONITOR, CARBON-DIOXIDE, CUTANEOUS |
| Applicant | Kontron Cardiovascular |
| Product code | LKD |
| Received date | Sep 18, 1996 |
| Decision date | Nov 25, 1997 |
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: