HDE supplement
H040002 S005: INTACS® Corneal Implants
FDA HDE supplement · normal 75 day track · ADDITION TECHNOLOGY
Key facts
| Original HDE | H040002 |
|---|---|
| Supplement number | S005 |
| Supplement type | normal 75 day track |
| Reason for the supplement | location change - manufacturer/sterilizer/packager/supplier |
| Trade name | INTACS® Corneal Implants |
| Generic name | Implant, corneal, refractive |
| Applicant | ADDITION TECHNOLOGY |
| Product code | LQE |
| Received date | Feb 1, 2024 |
| Decision date | Sep 9, 2024 |
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: