PMA supplement
P980040 S065: TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS
FDA PMA supplement · Panel Track · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Original PMA | P980040 |
|---|---|
| Supplement number | S065 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS |
| Generic name | Extended depth of focus intraocular lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product code | POE |
| Received date | Jan 19, 2016 |
| Decision date | Jul 15, 2016 |
| Docket number | 16M-2184 |
| Notice date | Jul 25, 2016 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: