PMA
P980006: PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR
FDA PMA · Lenses, soft contact, extended wear · Bausch & Lomb, Inc.
Key facts
| PMA number | P980006 |
|---|---|
| Trade name | PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | LPM |
| Approval date | Feb 5, 1999 |
| Docket number | 99M-0237 |
| Establishment registration | 1313525 |
| FEI number | 1317628 |
At a glance
- 10–99 Supplements
- Mar 17, 2025 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- No Withdrawn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: