PMA supplement
P060011 S015: Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses
FDA PMA supplement · Real-Time Process · Rayner Intraocular Lenses, Ltd.
Key facts
| Original PMA | P060011 |
|---|---|
| Supplement number | S015 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses |
| Generic name | Intraocular lens |
| Applicant | Rayner Intraocular Lenses , Ltd. |
| Product code | HQL |
| Received date | May 16, 2018 |
| Decision date | Apr 12, 2019 |
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: