PMA P180035S011

Device
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant
CooperVision, Inc.
PMA number
P180035
Supplement
S011
Product code
QIT
Decision date
2022-09-22
Generic name
Daily wear soft contact lens to reduce the progression of myopia
Approval order statement
Introduction of a secondary packaging line at the CooperVision. Inc. facility in West Henrietta. New York.

Current openFDA PMA Record#

Device
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant
CooperVision, Inc.
PMA number
P180035
Supplement
S011
Product code
QIT
Generic name
Daily wear soft contact lens to reduce the progression of myopia
Decision date
2022-09-22
Decision code
OK30
Date received
2022-08-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of a secondary packaging line at the CooperVision. Inc. facility in West Henrietta. New York.