HDE supplement
H000002 S001: VISX EXCIMER LASER SYSTEM
FDA HDE supplement · normal 75 day track · ABBOTT MEDICAL OPTICS INC
Key facts
| Original HDE | H000002 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | VISX EXCIMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Product code | LZS |
| Received date | Mar 7, 2002 |
| Decision date | May 10, 2002 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: