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.
Introduction of new reduced quality control sampling plan for lens dry process along with new inspection software
| Device | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear |
| Generic Name | Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia |
| Applicant | CooperVision, Inc. |
| Date Received | 2021-03-05 |
| Decision Date | 2021-03-26 |
| PMA | P180035 |
| Supplement | S007 |
| Product Code | QIT |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CooperVision, Inc. 5870 Stoneridge Drive suite 1 pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180035 | Original Filing | |
| S015 | 2022-12-19 | Normal 180 Day Track No User Fee |
| S014 | 2022-12-16 | 30-day Notice |
| S013 | 2022-12-14 | 30-day Notice |
| S012 | 2022-09-30 | Normal 180 Day Track No User Fee |
| S011 | 2022-08-23 | 30-day Notice |
| S010 | 2022-08-17 | 30-day Notice |
| S009 | 2021-12-29 | 30-day Notice |
| S008 | 2021-03-08 | 30-day Notice |
| S007 | 2021-03-05 | 30-day Notice |
| S006 | 2020-04-17 | Real-time Process |
| S005 | 2020-02-13 | 30-day Notice |
| S004 | ||
| S003 | ||
| S002 | 2020-01-09 | 30-day Notice |
| S001 | 2019-11-29 | Normal 180 Day Track No User Fee |