PMA supplement
P820019 S007: LIFESPAN(TM) 100 TCPCO2 MONITOR
FDA PMA supplement · Biochem International, Inc.
Key facts
| Original PMA | P820019 |
|---|---|
| Supplement number | S007 |
| Trade name | LIFESPAN(TM) 100 TCPCO2 MONITOR |
| Generic name | MONITOR, CARBON-DIOXIDE, CUTANEOUS |
| Applicant | Biochem International, Inc. |
| Product code | LKD |
| Received date | Jan 17, 1986 |
| Decision date | Mar 3, 1986 |
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: