PMA supplement
P130025 S002: KONING BREAST CT (MODEL CBCT 1000)
FDA PMA supplement · Normal 180 Day Track · Koning Corporation
Key facts
| Original PMA | P130025 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | KONING BREAST CT (MODEL CBCT 1000) |
| Generic name | Cross-sectional mammographic xray system |
| Applicant | Koning Corporation |
| Product code | OLQ |
| Received date | Dec 28, 2015 |
| Decision date | Oct 6, 2016 |
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: