PMA
P880070: MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS
FDA PMA · Intraocular lens · Abbott Medical Optics, Inc.
Key facts
| PMA number | P880070 |
|---|---|
| Trade name | MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS |
| Generic name | Intraocular lens |
| Applicant | Abbott Medical Optics, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | HQL |
| Approval date | Sep 20, 1989 |
| Docket number | 89M-0408 |
| Notice date | Oct 19, 1989 |
| Establishment registration | 3004936110 |
| FEI number | 3004936110 |
At a glance
- 10–99 Supplements
- May 8, 2007 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- Yes Withdrawn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: