PMA
P960039: SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
FDA PMA · Lenses, soft contact, extended wear · Unilens Corporation, USA
Key facts
| PMA number | P960039 |
|---|---|
| Trade name | SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR) |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Unilens Corporation, USA |
| Product code | LPM |
| Approval date | Apr 17, 1997 |
| Docket number | 97M-0272 |
| Notice date | Jul 8, 1997 |
| FEI number | 1119279 |
At a glance
- 1–9 Supplements
- Mar 3, 2008 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- Yes Withdrawn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: