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 addition of the following private label trade names for the menicon z night (tisilfocon a) contact lenses for overnight wear: acuvue® abiliti™ overnight and acuvue® abiliti™ overnight therapeutic lenses for myopia management
| Device | ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | MENICON CO. LTD. |
| Date Received | 2021-01-21 |
| Decision Date | 2021-05-06 |
| PMA | P990018 |
| Supplement | S006 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| 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 |
| 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 |