PMA supplement
P810044 S002: SLEEP SENTRY(TM)
FDA PMA supplement · Diabetes Sentry Products, LLC
Key facts
| Original PMA | P810044 |
|---|---|
| Supplement number | S002 |
| Trade name | SLEEP SENTRY(TM) |
| Generic name | Monitor, skin resistance/skin temperature, for insulin reactions |
| Applicant | Diabetes Sentry Products, LLC |
| Product code | LMY |
| Received date | Mar 16, 1983 |
| Decision date | Apr 27, 1983 |
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: