PMA supplement
P080011 S186: iWear oxygen presbyopia
FDA PMA supplement · Normal 180 Day Track No User Fee · CooperVision, Inc.
Key facts
| Original PMA | P080011 |
|---|---|
| Supplement number | S186 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | iWear oxygen presbyopia |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | CooperVision, Inc. |
| Product code | LPM |
| Received date | Mar 14, 2025 |
| Decision date | Aug 20, 2025 |
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: