PMA
P850039: B&L 58(TM) (ETAFILCONA) CONTACT LENS
FDA PMA · Lenses, soft contact, extended wear · Bausch & Lomb, Inc.
Key facts
| PMA number | P850039 |
|---|---|
| Trade name | B&L 58(TM) (ETAFILCONA) CONTACT LENS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | LPM |
| Approval date | Aug 16, 1985 |
| Docket number | 85M-0420 |
| Notice date | Sep 23, 1985 |
| Establishment registration | 1281950 |
| FEI number | 1281950 |
At a glance
- 1–9 Supplements
- Oct 30, 1991 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- Yes Withdrawn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: