PMA
P890029: EXCELENS (ATLAFILCON A) CONTACT LENS
FDA PMA · Lenses, soft contact, daily wear · Ciba Vision Corporation
Key facts
| PMA number | P890029 |
|---|---|
| Trade name | EXCELENS (ATLAFILCON A) CONTACT LENS |
| Generic name | Lenses, soft contact, daily wear |
| Applicant | Ciba Vision Corporation |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LPL |
| Approval date | Dec 28, 1989 |
| Docket number | 90M-0006 |
| Notice date | Jan 30, 1990 |
| Establishment registration | 9610813 |
| FEI number | 1030321 |
At a glance
- 1–9 Supplements
- Aug 2, 1993 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- Yes Withdrawn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: