PMA P080011S076

Device: comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S076
Product code: LPM
Decision date: 2018-07-02
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Addition of the capability to produce Biofinity XR Toric in 5° axis increment steps on Biofinity Line 3 at the CooperVision, Inc. manufacturing facility in Hamble, UK.

Current openFDA PMA Record#

Device: comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S076
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2018-07-02
Decision code: OK30
Date received: 2018-06-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of the capability to produce Biofinity XR Toric in 5° axis increment steps on Biofinity Line 3 at the CooperVision, Inc. manufacturing facility in Hamble, UK.