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 | 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.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS013 Date Received12/14/2022 Decision Date01/12/2023 Product Code QIT Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-12-14 |
| Decision Date | 2023-01-12 |
| PMA | P180035 |
| Supplement | S013 |
| 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 PMA NumberP180035 Supplement NumberS013 Date Received12/14/2022 Decision Date01/12/2023 Product Code QIT Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Manufacture Of MiSight 1 Day (omafilcon A) Product On Dry Line HD And Wet Line HVD At The Warrior Close Manufacturing Facility In Chandler's Ford, Eastleigh, UK |
| 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 |