PMA P080011S064

Device: Comflicon A Soft (Hydrophilic ) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S064
Product code: LPM
Decision date: 2017-12-12
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Reduction of the cycle time for the injection molding machine for Biofinity Toric (comfilcon A) extended wear soft (hydrophilic) contact lenses.

Current openFDA PMA Record#

Device: Comflicon A Soft (Hydrophilic ) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S064
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2017-12-12
Decision code: OK30
Date received: 2017-11-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduction of the cycle time for the injection molding machine for Biofinity Toric (comfilcon A) extended wear soft (hydrophilic) contact lenses.