HDE supplement
H110002 S028: Argus II Retinal Prosthesis System
FDA HDE supplement · special (immediate track) · Cortigent, Inc.
Key facts
| Original HDE | H110002 |
|---|---|
| Supplement number | S028 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | Argus II Retinal Prosthesis System |
| Generic name | Prosthesis, retinal |
| Applicant | Cortigent, Inc. |
| Product code | NBF |
| Received date | May 24, 2018 |
| Decision date | Jun 21, 2018 |
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: