HDE supplement
H040002 S003: INTACS PRESCRIPTION INSERTS FOR KERATOCONUS
FDA HDE supplement · 30-day notice · ADDITION TECHNOLOGY
Key facts
| Original HDE | H040002 |
|---|---|
| Supplement number | S003 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | INTACS PRESCRIPTION INSERTS FOR KERATOCONUS |
| Generic name | Implant, corneal, refractive |
| Applicant | ADDITION TECHNOLOGY |
| Product code | LQE |
| Received date | Nov 20, 2012 |
| Decision date | Dec 19, 2012 |
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: