HDE supplement
H110002 S032: Argus II/2s Retinal Prosthesis Systems
FDA HDE supplement · 30-day notice · Cortigent, Inc.
Key facts
| Original HDE | H110002 |
|---|---|
| Supplement number | S032 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | Argus II/2s Retinal Prosthesis Systems |
| Generic name | Prosthesis, retinal |
| Applicant | Cortigent, Inc. |
| Product code | NBF |
| Received date | Feb 22, 2021 |
| Decision date | Mar 18, 2021 |
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: