PMA supplement
P040020 S049: ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS
FDA PMA supplement · Panel Track · Alcon Research, Ltd.
Key facts
| Original PMA | P040020 |
|---|---|
| Supplement number | S049 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS |
| Generic name | Lens, multifocal intraocular |
| Applicant | Alcon Research, Ltd. |
| Product code | MFK |
| Received date | Aug 9, 2013 |
| Decision date | Dec 22, 2016 |
| Docket number | 16M-4657 |
| Notice date | Mar 7, 2017 |
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: