FDA.reportPublic FDA data

PMA P080011S073

Device
Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S073
Product code
LPM
Decision date
2018-04-10
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Changes in the injection molding machine processes for Biofinity Sphere XR (comfilcon A) lenses produced at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.

Current openFDA PMA Record#

Device
Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S073
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2018-04-10
Decision code
OK30
Date received
2018-03-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes in the injection molding machine processes for Biofinity Sphere XR (comfilcon A) lenses produced at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.