PMA supplement
P030016 S035: EVO/EVO+VISIAN Implantable Collamer Lens
FDA PMA supplement · Panel Track · STAAR Surgical Company
Key facts
| Original PMA | P030016 |
|---|---|
| Supplement number | S035 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | EVO/EVO+VISIAN Implantable Collamer Lens |
| Generic name | Lens, intraocular, phakic |
| Applicant | STAAR Surgical Company |
| Product code | MTA |
| Received date | Nov 1, 2018 |
| Decision date | Mar 25, 2022 |
| Docket number | 22M-0462 |
| Notice date | Mar 29, 2022 |
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: