PMA
P800027: BINKHORST & FEDOROV I IRIS CLIP IOLS
FDA PMA · Intraocular lens · Storz Ophthalmics, Inc.
Key facts
| PMA number | P800027 |
|---|---|
| Trade name | BINKHORST & FEDOROV I IRIS CLIP IOLS |
| Generic name | Intraocular lens |
| Applicant | Storz Ophthalmics, Inc. |
| Product code | HQL |
| Approval date | Jul 26, 1982 |
| Docket number | 82M-0257 |
| Notice date | Aug 31, 1982 |
At a glance
- None Supplements
- Jul 26, 1982 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- Yes Withdrawn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: