PMA supplement
P800043 S001: RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
FDA PMA supplement · Radiometer America, Inc.
Key facts
| Original PMA | P800043 |
|---|---|
| Supplement number | S001 |
| Trade name | RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO |
| Generic name | MONITOR, CARBON-DIOXIDE, CUTANEOUS |
| Applicant | Radiometer America, Inc. |
| Product code | LKD |
| Received date | Aug 25, 1981 |
| Decision date | Sep 21, 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: