PMA supplement
P970053 S002: NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA PMA supplement · Panel Track · Nidek Co., Ltd.
Key facts
| Original PMA | P970053 |
|---|---|
| Supplement number | S002 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | NIDEK EC-5000 EXCIMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | Nidek Co., Ltd. |
| Product code | LZS |
| Received date | Apr 19, 1999 |
| Decision date | Apr 14, 2000 |
| Docket number | 01M-0014 |
| Notice date | Jan 16, 2001 |
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: