PMA
P790028: BIOSTATOR GCIIS
FDA PMA · Controller, closed-loop blood glucose · Bayer Healthcare
Key facts
| PMA number | P790028 |
|---|---|
| Trade name | BIOSTATOR GCIIS |
| Generic name | Controller, closed-loop blood glucose |
| Applicant | Bayer Healthcare |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | LHE |
| Approval date | Dec 4, 1980 |
| Notice date | Feb 20, 1981 |
| Establishment registration | 3009448641 |
| FEI number | 3002755490 |
At a glance
- 1–9 Supplements
- Aug 8, 1983 Latest supplement decision
- Yes Withdrawn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: