PMA P180035S031

Device: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S031
Product code: QIT
Decision date: 2025-10-28
Classification: Ophthalmic
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Approval order statement: Approval of protocol changes to enroll approximately 1000 subjects in PAS002 to achieve at least 4000 patient years total (approximately 2000 per study) with an average follow up of 2-3 years per subject. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180035.

Current openFDA PMA Record#

Device: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S031
Product code: QIT
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Decision date: 2025-10-28
Decision code: APPR
Date received: 2025-08-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of protocol changes to enroll approximately 1000 subjects in PAS002 to achieve at least 4000 patient years total (approximately 2000 per study) with an average follow up of 2-3 years per subject. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180035.