PMA supplement
P930016 S005: VISX EXCIMER LASER SYSTEM MODELS B AND C
FDA PMA supplement · Panel Track · Amo Manufacturing USA, LLC
Key facts
| Original PMA | P930016 |
|---|---|
| Supplement number | S005 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | VISX EXCIMER LASER SYSTEM MODELS B AND C |
| Generic name | Excimer laser system |
| Applicant | Amo Manufacturing USA, LLC |
| Product code | LZS |
| Received date | Jul 23, 1997 |
| Decision date | Jan 29, 1998 |
| Docket number | 99M-0293 |
| Notice date | Jul 15, 1999 |
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: