PMA
P820021: SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS
FDA PMA · Lenses, soft contact, extended wear · Alcon Laboratories, Inc.
Key facts
| PMA number | P820021 |
|---|---|
| Trade name | SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Alcon Laboratories, Inc. |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LPM |
| Approval date | Mar 31, 1983 |
| Docket number | 83M-0123 |
| Notice date | Apr 29, 1983 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- May 8, 2013 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- Yes Withdrawn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: