PMA
P880072: MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL
FDA PMA · Intraocular lens · Eyekon Medical, Inc.
Key facts
| PMA number | P880072 |
|---|---|
| Trade name | MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL |
| Generic name | Intraocular lens |
| Applicant | Eyekon Medical, Inc. |
| Owner/operator | EYEKON MEDICAL, INC. |
| Product code | HQL |
| Approval date | Sep 22, 1989 |
| Establishment registration | 1038833 |
| FEI number | 1038833 |
At a glance
- 10–99 Supplements
- Jun 20, 2000 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1,000+ 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: