PMA
P990072: W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES
FDA PMA · Lenses, soft contact, extended wear · Westcon Contact Lens Co., Inc.
Key facts
| PMA number | P990072 |
|---|---|
| Trade name | W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Westcon Contact Lens Co., Inc. |
| Product code | LPM |
| Approval date | Aug 22, 2000 |
| Docket number | 00M-1475 |
| Notice date | Aug 31, 2000 |
At a glance
- None Supplements
- Aug 22, 2000 Latest supplement decision
- Yes Withdrawn
- Yes 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: