FDA.reportPublic FDA data

PMA P080011S102

Device
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S102
Product code
LPM
Decision date
2020-03-12
Generic name
Lenses, soft contact, extended wear
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
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S102
Product code
LPM
Generic name
Lenses, soft contact, extended wear
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.