PMA supplement
P060011 S010: C-FLEX MODEL 570C, C-Flex Aspheric 970C and 600 C Aspheric INTRAOCULAR LENS (IOL)
FDA PMA supplement · 30-Day Notice · Rayner Intraocular Lenses, Ltd.
Key facts
| Original PMA | P060011 |
|---|---|
| Supplement number | S010 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | C-FLEX MODEL 570C, C-Flex Aspheric 970C and 600 C Aspheric INTRAOCULAR LENS (IOL) |
| Generic name | Intraocular lens |
| Applicant | Rayner Intraocular Lenses , Ltd. |
| Product code | HQL |
| Received date | Aug 1, 2016 |
| Decision date | Aug 19, 2016 |
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: