PMA
P850072: DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
FDA PMA · Lenses, soft contact, daily wear · Ciba Vision Corporation
Key facts
| PMA number | P850072 |
|---|---|
| Trade name | DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS |
| Generic name | Lenses, soft contact, daily wear |
| Applicant | Ciba Vision Corporation |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LPL |
| Approval date | Jul 17, 1986 |
| Docket number | 86M-0325 |
| Notice date | Aug 14, 1986 |
| Establishment registration | 9610813 |
| FEI number | 3002806704 |
At a glance
- 1–9 Supplements
- Aug 29, 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- Yes Withdrawn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: