PMA P080011S081

Device
BIOFINITY (COMFILCON A)
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S081
Product code
LPM
Decision date
2018-10-15
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Introduction of Biofinity line 18.

Current openFDA PMA Record#

Device
BIOFINITY (COMFILCON A)
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S081
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2018-10-15
Decision code
OK30
Date received
2018-09-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of Biofinity line 18.