PMA supplement
P930014 S126: AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A
FDA PMA supplement · Panel Track · Alcon Laboratories, Inc.
Key facts
| Original PMA | P930014 |
|---|---|
| Supplement number | S126 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A |
| Generic name | Extended depth of focus intraocular lens |
| Applicant | Alcon Laboratories, Inc. |
| Product code | POE |
| Received date | Aug 9, 2019 |
| Decision date | Feb 26, 2020 |
| Docket number | 20M-0986 |
| Notice date | Feb 28, 2020 |
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: