This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the menicon z(tm) (tisilfocon a) rigid gas permeable lens. Menicon z(tm) (tisilfocon a) spherical or aspheric lenses and non-prism ballast toric lenses are indicated for extended wear (from 1 to 7 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare practitioner) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes. The lens may be disinfected using a...
| Device | MENICON Z RIGID GAS PERMEABLE CONTACT LENS |
| Classification Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Generic Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Applicant | MENICON CO. LTD. |
| Date Received | 1999-03-18 |
| Decision Date | 2000-07-11 |
| Notice Date | 2000-07-25 |
| PMA | P990018 |
| Supplement | S |
| Product Code | MWL |
| Docket Number | 00M-1414 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MENICON CO. LTD. 269 A Ballardvale Street wilmington, MA 01887 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990018 | Original Filing | |
| S008 | 2022-02-07 | Normal 180 Day Track |
| S007 | ||
| S006 | 2021-01-21 | Normal 180 Day Track No User Fee |
| S005 | 2018-11-28 | Normal 180 Day Track |
| S004 | 2009-04-01 | Normal 180 Day Track No User Fee |
| S003 | 2002-10-21 | Real-time Process |
| S002 | 2001-11-28 | Panel Track |
| S001 | 2000-07-28 | Normal 180 Day Track |