PMA P080011S153

Device: Biofinity Sphere and Biofmity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S153
Product code: LPM
Decision date: 2023-01-19
Generic name: Lenses, soft contact, extended wear
Approval order statement: Change in carrier gas of two gas chromatography (GC) methods for analyzing raw materials at the CooperVision Manufacturing Puerto Rico LLC facility.

Current openFDA PMA Record#

Device: Biofinity Sphere and Biofmity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S153
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2023-01-19
Decision code: OK30
Date received: 2022-12-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in carrier gas of two gas chromatography (GC) methods for analyzing raw materials at the CooperVision Manufacturing Puerto Rico LLC facility.