PMA
P820078: AL-47 SOFT CONTACT LENS
FDA PMA · Lenses, soft contact, daily wear · Alden Optical Labs., Inc.
Key facts
| PMA number | P820078 |
|---|---|
| Trade name | AL-47 SOFT CONTACT LENS |
| Generic name | Lenses, soft contact, daily wear |
| Applicant | Alden Optical Labs., Inc. |
| Product code | LPL |
| Approval date | Jan 30, 1984 |
| Docket number | 84M-0055 |
| Notice date | Mar 9, 1984 |
At a glance
- None Supplements
- Jan 30, 1984 Latest supplement decision
- No Withdrawn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: