PMA P080011S146

Device: Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S146
Product code: LPM
Decision date: 2022-07-25
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for the introduction of a new primary packaging foil for Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear.

Current openFDA PMA Record#

Device: Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S146
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-07-25
Decision code: APPR
Date received: 2022-04-27
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the introduction of a new primary packaging foil for Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear.