PMA supplement
P990018 S007: Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight
FDA PMA supplement · Normal 180 Day Track · Menicon Co, Ltd.
Key facts
| Original PMA | P990018 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | Menicon Co, Ltd. |
| Product code | MWL |
| Received date | Jul 16, 2021 |
| Decision date | Nov 16, 2022 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: