PMA P180035S004
- Device
- MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
- Applicant
- CooperVision, Inc.
- Product code
- QIT
- Decision date
- 2021-07-12
- Generic name
- Daily wear soft contact lens to reduce the progression of myopia
- Approval order statement
- Approval of the protocol for the MiSight®1 Day Safety Post Approval Study (PAS) protocol.
Current openFDA PMA Record#
- Device
- MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P180035
- Supplement
- S004
- Product code
- QIT
- Generic name
- Daily wear soft contact lens to reduce the progression of myopia
- Decision date
- 2021-07-12
- Decision code
- APPR
- Date received
- 2020-01-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the MiSight®1 Day Safety Post Approval Study (PAS) protocol.