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.
| Device | Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | MENICON CO. LTD.21-19, Aoi 3-chome, Naka-kunagoya Aichi 460-0-0006 PMA NumberP990018 Supplement NumberS008 Date Received02/07/2022 Decision Date08/02/2022 Product Codes MWL NUU Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-08-02 |
| PMA | P990018 |
| Supplement | S008 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MENICON CO. LTD. 21-19, Aoi 3-chome, Naka-ku nagoya Aichi 460-0-0006 PMA NumberP990018 Supplement NumberS008 Date Received02/07/2022 Decision Date08/02/2022 Product Codes MWL NUU Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For An Expanded Range Of Myopia Treatment Of Up To 6.00 Diopters (manifest Spherical Equivalent) |
| 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 |