PMA
P790010: DANKER SILICONE LENS (DIMEFOCON-A)
FDA PMA · Lens, contact (other material) - daily · Ciba Vision Corporation
Key facts
| PMA number | P790010 |
|---|---|
| Trade name | DANKER SILICONE LENS (DIMEFOCON-A) |
| Generic name | Lens, contact (other material) - daily |
| Applicant | Ciba Vision Corporation |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | HQD |
| Approval date | May 28, 1982 |
| Notice date | Jul 13, 1982 |
| Establishment registration | 9610813 |
| FEI number | 1000115040 |
At a glance
- 1–9 Supplements
- Jan 23, 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- Yes Withdrawn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: