PMA
P830040: STYLES 30 & 31 POSTERIOR CHAMBER IOLS
FDA PMA · Intraocular lens · Alcon Research, Ltd.
Key facts
| PMA number | P830040 |
|---|---|
| Trade name | STYLES 30 & 31 POSTERIOR CHAMBER IOLS |
| Generic name | Intraocular lens |
| Applicant | Alcon Research, Ltd. |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | HQL |
| Approval date | Sep 5, 1985 |
| Docket number | 85M-0451 |
| Notice date | Oct 17, 1985 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Sep 4, 1998 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: