PMA
P890020: FLUOROCON TM-60
FDA PMA · Lens, contact (rigid gas permeable), extended wear · Ciba Vision Corporation
Key facts
| PMA number | P890020 |
|---|---|
| Trade name | FLUOROCON TM-60 |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | Ciba Vision Corporation |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | MWL |
| Approval date | Jun 23, 1989 |
| Docket number | 89M-0313 |
| Notice date | Aug 24, 1989 |
| Establishment registration | 9610813 |
| FEI number | 1030321 |
At a glance
- 1–9 Supplements
- Dec 28, 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- Yes Withdrawn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: