PMA
P880091: ELASTIC UVA PC IOL.
FDA PMA · Intraocular lens · Staar Surgical Co.
Key facts
| PMA number | P880091 |
|---|---|
| Trade name | ELASTIC UVA PC IOL. |
| Generic name | Intraocular lens |
| Applicant | Staar Surgical Co. |
| Owner/operator | STAAR SURGICAL Company |
| Product code | HQL |
| Approval date | Sep 16, 1991 |
| Docket number | 91M-0380 |
| Notice date | Nov 12, 1991 |
| Establishment registration | 2023826 |
| FEI number | 2023826 |
At a glance
- 10–99 Supplements
- Sep 16, 2010 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: