PMA P080011S062

Device
Biofinity Toric
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S062
Product code
LPM
Decision date
2017-11-13
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Validate Biofinity Line 12 to produce Biofinity Toric lenses.

Current openFDA PMA Record#

Device
Biofinity Toric
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S062
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2017-11-13
Decision code
OK30
Date received
2017-10-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Validate Biofinity Line 12 to produce Biofinity Toric lenses.