PMA supplement
P170029 S003: CALCIVIS Imaging System
FDA PMA supplement · Panel Track · Calcivis Limited
Key facts
| Original PMA | P170029 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | CALCIVIS Imaging System |
| Generic name | Caries detection product with drug or biologic |
| Applicant | Calcivis Limited |
| Product code | QJX |
| Received date | Sep 12, 2023 |
| Decision date | Oct 13, 2023 |
| Docket number | 24M-4267 |
| Notice date | Sep 17, 2024 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: