PMA
P080004: HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
FDA PMA · Intraocular lens · Hoya Surgical Optics, Inc.
Key facts
| PMA number | P080004 |
|---|---|
| Trade name | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS |
| Generic name | Intraocular lens |
| Applicant | Hoya Surgical Optics, Inc. |
| Owner/operator | Hoya Surgical Optics, Inc. |
| Product code | HQL |
| Approval date | Sep 26, 2008 |
| Docket number | 08M-0536 |
| Notice date | Oct 7, 2008 |
| Establishment registration | 3006723646 |
| FEI number | 3006723646 |
At a glance
- 10–99 Supplements
- Oct 25, 2023 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: