PMA
P850078: KONTUR 55 EW
FDA PMA · Lenses, soft contact, extended wear · Kontur Kontact Lens Co., Inc.
Key facts
| PMA number | P850078 |
|---|---|
| Trade name | KONTUR 55 EW |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Kontur Kontact Lens Co., Inc. |
| Owner/operator | KONTUR KONTACT LENS CO., INC. |
| Product code | LPM |
| Approval date | Jan 31, 1986 |
| Docket number | 86M-0109 |
| Notice date | Mar 28, 1986 |
| Establishment registration | 2919245 |
| FEI number | 2919245 |
At a glance
- 10–99 Supplements
- Jan 3, 1990 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- Yes Withdrawn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: