PMA supplement
P970043 S015: LADARVISION 4000 EXCIMER LASER SYSTEM
FDA PMA supplement · Panel Track · Alcon Laboratories
Key facts
| Original PMA | P970043 |
|---|---|
| Supplement number | S015 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | LADARVISION 4000 EXCIMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | Alcon Laboratories |
| Product code | LZS |
| Received date | Sep 30, 2003 |
| Decision date | Jun 29, 2004 |
| Docket number | 04M-0312 |
| Notice date | Jul 16, 2004 |
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: