PMA P180035S009

Device: MiSight 1 Day (omafilcon A)
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S009
Product code: QIT
Decision date: 2022-01-26
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Approval order statement: Adding additional three packaging and labeling lines for MiSight 1 day (omafilcon A) product at the CooperVision, Inc., Distribution Facility at West Henrietta, NY, USA.

Current openFDA PMA Record#

Device: MiSight 1 Day (omafilcon A)
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S009
Product code: QIT
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Decision date: 2022-01-26
Decision code: OK30
Date received: 2021-12-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Adding additional three packaging and labeling lines for MiSight 1 day (omafilcon A) product at the CooperVision, Inc., Distribution Facility at West Henrietta, NY, USA.