PMA supplement
P030016 S046: Visian ICL (Implantable Collamer Lens), Visian Toric ICL (Implantable Collamer Lens), Visian EVO/EVO+ ICL (Implantable C
FDA PMA supplement · 30-Day Notice · STAAR Surgical Company
Key facts
| Original PMA | P030016 |
|---|---|
| Supplement number | S046 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Visian ICL (Implantable Collamer Lens), Visian Toric ICL (Implantable Collamer Lens), Visian EVO/EVO+ ICL (Implantable C |
| Generic name | Lens, intraocular, phakic |
| Applicant | STAAR Surgical Company |
| Product code | MTA |
| Received date | May 1, 2024 |
| Decision date | May 10, 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: