PMA
P850068: SILSOFT (ELASTOFILCON A) CONTACT LENSES
FDA PMA · Lenses, soft contact, extended wear · Bausch & Lomb, Inc.
Key facts
| PMA number | P850068 |
|---|---|
| Trade name | SILSOFT (ELASTOFILCON A) CONTACT LENSES |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | LPM |
| Approval date | Dec 31, 1985 |
| Docket number | 86M-0030 |
| Notice date | Feb 10, 1986 |
| Establishment registration | 1281950 |
| FEI number | 1281950 |
At a glance
- 10–99 Supplements
- Mar 18, 2022 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: