PMA supplement
P220030 S008: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System
FDA PMA supplement · Real-Time Process · Alcon Research, LLC
Key facts
| Original PMA | P220030 |
|---|---|
| Supplement number | S008 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System |
| Generic name | Gases used within eye to place pressure on detached retina |
| Applicant | Alcon Research, LLC |
| Product code | LPO |
| Received date | Aug 28, 2025 |
| Decision date | Feb 10, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: