PMA
P890023: H55 HYDROPHILIC CONTACT LENS
FDA PMA · Lenses, soft contact, extended wear · The Cooper Companies
Key facts
| PMA number | P890023 |
|---|---|
| Trade name | H55 HYDROPHILIC CONTACT LENS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | The Cooper Companies |
| Owner/operator | COOPERVISION, INC. |
| Product code | LPM |
| Approval date | Sep 19, 1989 |
| Docket number | 89M-0472 |
| Notice date | Nov 27, 1989 |
| Establishment registration | 1314956 |
| FEI number | 1314956 |
At a glance
- 10–99 Supplements
- Dec 11, 2025 Latest supplement decision
- No Withdrawn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: