PMA supplement
P980040 S049: TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL)
FDA PMA supplement · Panel Track · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Original PMA | P980040 |
|---|---|
| Supplement number | S049 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL) |
| Generic name | Lens, multifocal intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product code | MFK |
| Received date | Jun 30, 2014 |
| Decision date | Dec 17, 2014 |
| Docket number | 14M-2375 |
| Notice date | Mar 19, 2015 |
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: