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 NumberS012 Date Received09/30/2022 Decision Date12/07/2022 Product Code QIT Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-09-30 |
| Decision Date | 2022-12-07 |
| PMA | P180035 |
| Supplement | S012 |
| Product Code | QIT |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CooperVision, Inc. 5870 Stoneridge Drive suite 1 pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS012 Date Received09/30/2022 Decision Date12/07/2022 Product Code QIT Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P180035 |
| 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 |