PMA supplement
P980040 S112: TECNIS Symfony OptiBlue IOL, TECNIS Symfomy Toric II OptiBlue IOLs
FDA PMA supplement · Real-Time Process · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Original PMA | P980040 |
|---|---|
| Supplement number | S112 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | TECNIS Symfony OptiBlue IOL, TECNIS Symfomy Toric II OptiBlue IOLs |
| Generic name | Extended depth of focus intraocular lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product code | POE |
| Received date | Feb 28, 2020 |
| Decision date | May 28, 2020 |
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: