PMA supplement
P030016 S001: Visian Toric ICL (IMPLANTABLE COLLAMER LENS)
FDA PMA supplement · Panel Track · STAAR Surgical Company
Key facts
| Original PMA | P030016 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Visian Toric ICL (IMPLANTABLE COLLAMER LENS) |
| Generic name | Phakic toric intraocular lens |
| Applicant | STAAR Surgical Company |
| Product code | QCB |
| Received date | Apr 28, 2006 |
| Decision date | Sep 13, 2018 |
| Docket number | 18M-3503 |
| Notice date | Sep 20, 2018 |
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: