FDA.reportPublic FDA data

PMA P180035S005

Device
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant
CooperVision, Inc.
PMA number
P180035
Supplement
S005
Product code
QIT
Decision date
2020-03-12
Generic name
Daily wear soft contact lens to reduce the progression of myopia
Approval order statement
Introduction of a new Total Organic Carbon (TOC) analyzer for the testing of purified water supplies at the CooperVision Manufacturing, Ltd. facilities located in Hamble, UK and Chandlers Ford, UK.

Current openFDA PMA Record#

Device
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant
CooperVision, Inc.
PMA number
P180035
Supplement
S005
Product code
QIT
Generic name
Daily wear soft contact lens to reduce the progression of myopia
Decision date
2020-03-12
Decision code
OK30
Date received
2020-02-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of a new Total Organic Carbon (TOC) analyzer for the testing of purified water supplies at the CooperVision Manufacturing, Ltd. facilities located in Hamble, UK and Chandlers Ford, UK.