PMA supplement
P970043 S007: LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)
FDA PMA supplement · Panel Track · Alcon Laboratories
Key facts
| Original PMA | P970043 |
|---|---|
| Supplement number | S007 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA) |
| Generic name | Excimer laser system |
| Applicant | Alcon Laboratories |
| Product code | LZS |
| Received date | Sep 3, 1999 |
| Decision date | Sep 22, 2000 |
| Docket number | 00M-1612 |
| Notice date | Nov 21, 2000 |
At a glance
- Yes 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: