PMA
P840050: OCUSIL(TM) CONTACT LENS
FDA PMA · Lens, contact (other material) - daily · O.S.I. Corp.
Key facts
| PMA number | P840050 |
|---|---|
| Trade name | OCUSIL(TM) CONTACT LENS |
| Generic name | Lens, contact (other material) - daily |
| Applicant | O.S.I. Corp. |
| Product code | HQD |
| Approval date | Nov 20, 1985 |
| Docket number | 85M-0558 |
| Notice date | Jan 2, 1986 |
At a glance
- 10–99 Supplements
- Apr 14, 1993 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- No Withdrawn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: