PMA supplement
N62160 S009: MIC PANELS
FDA PMA supplement · American Micro Scan
Key facts
| Original PMA | N62160 |
|---|---|
| Supplement number | S009 |
| Trade name | MIC PANELS |
| Generic name | Panels, test, susceptibility, antimicrobial |
| Applicant | American Micro Scan |
| Product code | LTT |
| Received date | May 17, 1983 |
| Decision date | Sep 28, 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: