PMA
P890040: SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS
FDA PMA · Lenses, soft contact, extended wear · Unilens Corp., USA
Key facts
| PMA number | P890040 |
|---|---|
| Trade name | SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Unilens Corp., USA |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | LPM |
| Approval date | Sep 28, 1989 |
| Docket number | 89M-0437 |
| Notice date | Nov 3, 1989 |
| Establishment registration | 1119279 |
| FEI number | 1119279 |
At a glance
- 1–9 Supplements
- Feb 29, 2016 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: