PMA P180035S021

Device
MiSight 1 Day (omafilcon A)
Applicant
CooperVision, Inc.
PMA number
P180035
Supplement
S021
Product code
QIT
Decision date
2024-05-31
Classification
Ophthalmic
Generic name
Daily wear soft contact lens to reduce the progression of myopia
Approval order statement
the 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)
Applicant
CooperVision, Inc.
PMA number
P180035
Supplement
S021
Product code
QIT
Generic name
Daily wear soft contact lens to reduce the progression of myopia
Decision date
2024-05-31
Decision code
OK30
Date received
2024-05-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
the introduction of a secondary packaging line at the CooperVision, Inc. facility in West Henrietta New York