PMA
P810044: DIABETES SENTRY
FDA PMA · Monitor, skin resistance/skin temperature, for insulin reactions · Diabetes Sentry Products, LLC
Key facts
| PMA number | P810044 |
|---|---|
| Trade name | DIABETES SENTRY |
| Generic name | Monitor, skin resistance/skin temperature, for insulin reactions |
| Applicant | Diabetes Sentry Products, LLC |
| Product code | LMY |
| Approval date | Jul 8, 1982 |
| Docket number | 82M-0243 |
| Notice date | Sep 17, 1982 |
| FEI number | 3003636198 |
At a glance
- 1–9 Supplements
- Apr 8, 2005 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: