PMA
P810055: MODELS 019B, 019C, 019E, 019F, 019J, & 019K
FDA PMA · Intraocular lens · Advanced Medical Optics, Inc.
Key facts
| PMA number | P810055 |
|---|---|
| Trade name | MODELS 019B, 019C, 019E, 019F, 019J, & 019K |
| Generic name | Intraocular lens |
| Applicant | Advanced Medical Optics, Inc. |
| Owner/operator | OPTICS INCORPORATED |
| Product code | HQL |
| Approval date | Feb 3, 1983 |
| Docket number | 83M-0047 |
| Notice date | Feb 25, 1983 |
| Establishment registration | 3017541416 |
| FEI number | 3017541416 |
At a glance
- 10–99 Supplements
- Jul 2, 2008 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: