- Device
- MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P180035
- Supplement
- S008
- Product code
- QIT
- Generic name
- Daily wear soft contact lens to reduce the progression of myopia
- Decision date
- 2021-03-26
- Decision code
- OK30
- Date received
- 2021-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introducing an alternative supplier of sealer heads used in the blister sealing process.