PMA
P880081: UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA PMA · Intraocular lens · Johnson & Johnson Surgical Vision, Inc.
Key facts
| PMA number | P880081 |
|---|---|
| Trade name | UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES |
| Generic name | Intraocular lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Owner/operator | Johnson & Johnson Surgical Vision, Inc. |
| Product code | HQL |
| Approval date | Oct 31, 1989 |
| Docket number | 89M-0475 |
| Notice date | Nov 27, 1989 |
| Establishment registration | 3012236936 |
| FEI number | 3012236936 |
At a glance
- 10–99 Supplements
- Sep 27, 2024 Latest supplement decision
- No Withdrawn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: