PMA P180035S001

Device: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S001
Product code: QIT
Decision date: 2020-02-05
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Approval order statement: Approval for a repackaging/relabeling site located at CooperVision Manufacturing, Ltd., Mountpark, Unit 1, Wide Lane, Southampton, United Kingdom SO18 2NQ.

Current openFDA PMA Record#

Device: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S001
Product code: QIT
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Decision date: 2020-02-05
Decision code: APPR
Date received: 2019-11-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a repackaging/relabeling site located at CooperVision Manufacturing, Ltd., Mountpark, Unit 1, Wide Lane, Southampton, United Kingdom SO18 2NQ.