PMA
P990018: MENICON Z RIGID GAS PERMEABLE CONTACT LENS
FDA PMA · Lens, contact (rigid gas permeable), extended wear · Menicon Co, Ltd.
Key facts
| PMA number | P990018 |
|---|---|
| Trade name | MENICON Z RIGID GAS PERMEABLE CONTACT LENS |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | Menicon Co, Ltd. |
| Owner/operator | MENICON CO. LTD. |
| Product code | MWL |
| Approval date | Jul 11, 2000 |
| Docket number | 00M-1414 |
| Notice date | Jul 25, 2000 |
| Establishment registration | 9614761 |
| FEI number | 1000188353 |
At a glance
- 10–99 Supplements
- Jun 16, 2023 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: