This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for modified labeling to include information regarding the post-approval study.
| Device | MENICON Z (TISILFOCON A) 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 | 2009-04-01 |
| Decision Date | 2010-02-25 |
| PMA | P990018 |
| Supplement | S004 |
| Product Code | MWL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MENICON CO. LTD. 269 A Ballardvale Street wilmington, MA 01887 |
| 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 |