PMA supplement
P990018 S002: MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR
FDA PMA supplement · Panel Track · Menicon Co, Ltd.
Key facts
| Original PMA | P990018 |
|---|---|
| Supplement number | S002 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | Menicon Co, Ltd. |
| Product code | MWL |
| Received date | Nov 28, 2001 |
| Decision date | Jul 12, 2002 |
| Docket number | 02M-0335 |
| Notice date | Aug 6, 2002 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: