PMA supplement
P030016 S045: EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),
FDA PMA supplement · Normal 180 Day Track No User Fee · STAAR Surgical Company
Key facts
| Original PMA | P030016 |
|---|---|
| Supplement number | S045 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO), |
| Generic name | Lens, intraocular, phakic |
| Applicant | STAAR Surgical Company |
| Product code | MTA |
| Received date | Apr 12, 2024 |
| Decision date | Oct 1, 2024 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: