PMA
P830037: DURASOFT(R) 3 FOR EXT WEAR
FDA PMA · Lenses, soft contact, extended wear · Alcon Laboratories, Inc.
Key facts
| PMA number | P830037 |
|---|---|
| Trade name | DURASOFT(R) 3 FOR EXT WEAR |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Alcon Laboratories, Inc. |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LPM |
| Approval date | Apr 24, 1984 |
| Docket number | 84M-0164 |
| Notice date | May 31, 1984 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Nov 8, 2012 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- Yes Withdrawn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: