PMA supplement
P060011 S025: RayOne EMV (Model RAO200E)
FDA PMA supplement · Normal 180 Day Track · Rayner Intraocular Lenses, Ltd.
Key facts
| Original PMA | P060011 |
|---|---|
| Supplement number | S025 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | RayOne EMV (Model RAO200E) |
| Applicant | Rayner Intraocular Lenses , Ltd. |
| Received date | Aug 14, 2020 |
| Decision date | Mar 26, 2021 |
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: