PMA supplement
P980040 S142: TECNIS Symfony™ OptiBlue® Extended Range of Vision (ERV) IOL with TECNIS Simplicity® Delivery System, Model DXR00V; TECN
FDA PMA supplement · Real-Time Process · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Original PMA | P980040 |
|---|---|
| Supplement number | S142 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | TECNIS Symfony™ OptiBlue® Extended Range of Vision (ERV) IOL with TECNIS Simplicity® Delivery System, Model DXR00V; TECN |
| Generic name | Intraocular lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product code | HQL |
| Received date | Oct 1, 2021 |
| Decision date | Dec 23, 2021 |
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: