HDE
H110002: ARGUS II RETINAL PROSTHESIS SYSTEM
FDA Humanitarian Device Exemption · SECOND SIGHT, LLC.
Key facts
| HDE number | H110002 |
|---|---|
| Trade name | ARGUS II RETINAL PROSTHESIS SYSTEM |
| Generic name | Prosthesis, retinal |
| Applicant | SECOND SIGHT, LLC. |
| Owner/operator | Cortigent, Inc |
| Product code | NBF |
| Approval date | Feb 13, 2013 |
| Docket number | M-0205 |
| Notice date | Feb 13, 2013 |
| Establishment registration | 3004081696 |
| FEI number | 3004081696 |
At a glance
- 10–99 Supplements
- Aug 13, 2021 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 10–99 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: