PMA supplement
P060004 S006: MEL90
FDA PMA supplement · Panel Track · Carl Zeiss Meditec, Inc.
Key facts
| Original PMA | P060004 |
|---|---|
| Supplement number | S006 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MEL90 |
| Generic name | Excimer laser system |
| Applicant | Carl Zeiss Meditec, Inc. |
| Product code | LZS |
| Received date | Aug 21, 2023 |
| Decision date | Dec 4, 2024 |
| Docket number | 24M-5643 |
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: