PMA supplement
P970053 S001: NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)
FDA PMA supplement · Panel Track · Nidek Co., Ltd.
Key facts
| Original PMA | P970053 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK) |
| Generic name | Excimer laser system |
| Applicant | Nidek Co., Ltd. |
| Product code | LZS |
| Received date | Feb 16, 1999 |
| Decision date | Sep 29, 1999 |
| Docket number | 00M-1664 |
| Notice date | Dec 13, 2000 |
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: