PMA
P880085: MODEL 405 SPANFLEX TM IOL
FDA PMA · Intraocular lens · Advanced Medical Optics, Inc.
Key facts
| PMA number | P880085 |
|---|---|
| Trade name | MODEL 405 SPANFLEX TM IOL |
| Generic name | Intraocular lens |
| Applicant | Advanced Medical Optics, Inc. |
| Owner/operator | OPTICS INCORPORATED |
| Product code | HQL |
| Approval date | Jun 27, 1991 |
| Docket number | 91M-0247 |
| Notice date | Aug 2, 1991 |
| Establishment registration | 3017541416 |
| FEI number | 3017541416 |
At a glance
- 1–9 Supplements
- Oct 7, 1996 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- Yes Withdrawn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: