PMA
P990085: VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
FDA PMA · Lenses, soft contact, extended wear · Johnson & Johnson Vision Care, Inc.
Key facts
| PMA number | P990085 |
|---|---|
| Trade name | VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Johnson & Johnson Vision Care, Inc. |
| Owner/operator | Johnson & Johnson Vision Care, Inc. |
| Product code | LPM |
| Approval date | Feb 16, 2001 |
| Docket number | 01M-0149 |
| Notice date | Mar 26, 2001 |
| Establishment registration | 1057985 |
| FEI number | 1000222023 |
At a glance
- 1–9 Supplements
- Sep 19, 2001 Latest supplement decision
- Yes Withdrawn
- Yes 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: