PMA supplement
P930034 S013: SVS APEX PLUS EXCIMER LASER WORKSTATION
FDA PMA supplement · Panel Track · Alcon Laboratories, Inc.
Key facts
| Original PMA | P930034 |
|---|---|
| Supplement number | S013 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | SVS APEX PLUS EXCIMER LASER WORKSTATION |
| Generic name | Excimer laser system |
| Applicant | Alcon Laboratories, Inc. |
| Product code | LZS |
| Received date | Feb 11, 1999 |
| Decision date | Oct 21, 1999 |
| Docket number | 00M-1591 |
| Notice date | Nov 3, 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: