PMA supplement
P030008 S004: WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
FDA PMA supplement · Panel Track · Alcon Laboratories, Inc.
Key facts
| Original PMA | P030008 |
|---|---|
| Supplement number | S004 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | Alcon Laboratories, Inc. |
| Product code | LZS |
| Received date | Oct 24, 2005 |
| Decision date | Apr 19, 2006 |
| Docket number | 06M-0199 |
| Notice date | May 12, 2006 |
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: