PMA
P800032: BIOSTATOR GLUCOSE CONTROLLER
FDA PMA · Controller, closed-loop blood glucose · Miles Laboratories, Inc.
Key facts
| PMA number | P800032 |
|---|---|
| Trade name | BIOSTATOR GLUCOSE CONTROLLER |
| Generic name | Controller, closed-loop blood glucose |
| Applicant | Miles Laboratories, Inc. |
| Product code | LHE |
| Approval date | May 28, 1981 |
| Notice date | Jun 19, 1981 |
At a glance
- 1–9 Supplements
- Jun 2, 1983 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- No Withdrawn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: