- Device
- MiSight 1 day (omafilcon A)
- Applicant
- CooperVision, Inc.
- PMA number
- P180035
- Supplement
- S010
- Product code
- QIT
- Generic name
- Daily wear soft contact lens to reduce the progression of myopia
- Decision date
- 2022-09-15
- Decision code
- OK30
- Date received
- 2022-08-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacture of MiSight 1 Day product on Dry Line HE and Wet Line HVE at the CooperVision Warrior Close manufacturing facility in Chandlers Ford, Eastleigh, UK.