PMA supplement
P970053 S013: NIDEK EXCIMER LASER SYSTEM EC-5000
FDA PMA supplement · Normal 180 Day Track · Nidek Co., Ltd.
Key facts
| Original PMA | P970053 |
|---|---|
| Supplement number | S013 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | NIDEK EXCIMER LASER SYSTEM EC-5000 |
| Generic name | Excimer laser system |
| Applicant | Nidek Co., Ltd. |
| Product code | LZS |
| Received date | Feb 11, 2014 |
| Decision date | Nov 21, 2014 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: