PMA supplement
P060011 S026: C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, RayOne Aspheric
FDA PMA supplement · Real-Time Process · Rayner Intraocular Lenses, Ltd.
Key facts
| Original PMA | P060011 |
|---|---|
| Supplement number | S026 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, RayOne Aspheric |
| Generic name | Intraocular lens |
| Applicant | Rayner Intraocular Lenses , Ltd. |
| Product code | HQL |
| Received date | Feb 1, 2021 |
| Decision date | Apr 27, 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: