PMA
P890068: MODEL P-11 MODIFIED J-LOOP POSTERIOR CHAMBER IOL
FDA PMA · Intraocular lens · Chiron Ophthalmics
Key facts
| PMA number | P890068 |
|---|---|
| Trade name | MODEL P-11 MODIFIED J-LOOP POSTERIOR CHAMBER IOL |
| Generic name | Intraocular lens |
| Applicant | Chiron Ophthalmics |
| Product code | HQL |
| Approval date | Jan 11, 1990 |
At a glance
- 1–9 Supplements
- Oct 22, 1993 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- No Withdrawn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: