PMA P080011S086

Device: Biofinity XR Toric (comfilcon A)
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S086
Product code: LPM
Decision date: 2019-01-11
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Addition of the option to perform the lathe cut as a 2-step process in the manufacture of the Biofinity XR Toric (comfilcon A) Soft (hydrophilic) Extended Wear Contact Lenses.

Current openFDA PMA Record#

Device: Biofinity XR Toric (comfilcon A)
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S086
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-01-11
Decision code: OK30
Date received: 2018-12-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of the option to perform the lathe cut as a 2-step process in the manufacture of the Biofinity XR Toric (comfilcon A) Soft (hydrophilic) Extended Wear Contact Lenses.