PMA supplement
P060011 S036: Rayner c.. flex 570C, C-flex Aspheric 97 C, 600C Aspheric lntraocular lenses, RayOne Aspheric RAO600C, RayOne Spheric R
FDA PMA supplement · Real-Time Process · Rayner Intraocular Lenses, Ltd.
Key facts
| Original PMA | P060011 |
|---|---|
| Supplement number | S036 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Rayner c .. flex 570C, C-flex Aspheric 97 C, 600C Aspheric lntraocular lenses, RayOne Aspheric RAO600C, RayOne Spheric R |
| Generic name | Intraocular lens |
| Applicant | Rayner Intraocular Lenses , Ltd. |
| Product code | HQL |
| Received date | Nov 13, 2023 |
| Decision date | Feb 12, 2024 |
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: