PMA P080011S070

Device: Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S070
Product code: LPM
Decision date: 2018-02-26
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Reduction in the injection molding machine cycle time for Biofinity Multifocal and Biofinity Energys (comfilcon A) Extended Wear Soft Contact Lenses.

Current openFDA PMA Record#

Device: Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S070
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2018-02-26
Decision code: OK30
Date received: 2018-01-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduction in the injection molding machine cycle time for Biofinity Multifocal and Biofinity Energys (comfilcon A) Extended Wear Soft Contact Lenses.