PMA P180035S020
- Device
- MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P180035
- Supplement
- S020
- Product code
- QIT
- Decision date
- 2024-07-10
- Classification
- Ophthalmic
- Generic name
- Daily wear soft contact lens to reduce the progression of myopia
- Approval order statement
- Approval of the revised protocol for the MiSight 1 Day Safety post-approval study (PAS)
Current openFDA PMA Record#
- Device
- MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P180035
- Supplement
- S020
- Product code
- QIT
- Generic name
- Daily wear soft contact lens to reduce the progression of myopia
- Decision date
- 2024-07-10
- Decision code
- APPR
- Date received
- 2024-04-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the MiSight 1 Day Safety post-approval study (PAS)