PMA supplement
P060011 S012: Rayner C-flex 570C, C-Flex Aspheric 970C and 600C Aspheric Intraocular lenses
FDA PMA supplement · Normal 180 Day Track No User Fee · Rayner Intraocular Lenses, Ltd.
Key facts
| Original PMA | P060011 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| 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 | Jul 3, 2017 |
| Decision date | Jul 5, 2018 |
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: