PMA supplement
P790028 S001: BIOSTATOR GCIIS
FDA PMA supplement · Bayer Healthcare
Key facts
| Original PMA | P790028 |
|---|---|
| Supplement number | S001 |
| Trade name | BIOSTATOR GCIIS |
| Generic name | Controller, closed-loop blood glucose |
| Applicant | Bayer Healthcare |
| Product code | LHE |
| Received date | Oct 4, 1982 |
| Decision date | Nov 18, 1982 |
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: