PMA P080011S126

Device: Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S126
Product code: LPM
Decision date: 2021-04-22
Generic name: Lenses, soft contact, extended wear
Approval order statement: Modification in the packaging sampling plan and QA Final audit inspection regime performed post-autoclave for the Biofinity products.

Current openFDA PMA Record#

Device: Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S126
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2021-04-22
Decision code: OK30
Date received: 2021-03-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification in the packaging sampling plan and QA Final audit inspection regime performed post-autoclave for the Biofinity products.