PMA P080011S100

Device: Biofinity (comfilcon A) Toric Multifocal Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S100
Product code: LPM
Decision date: 2019-12-17
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for the addition of a new lens design, toric multifocal, for the Biofinity (comfilcon A) Soft (hydrophilic) Extended Wear Contact Lenses.

Current openFDA PMA Record#

Device: Biofinity (comfilcon A) Toric Multifocal Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S100
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-12-17
Decision code: APPR
Date received: 2019-09-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of a new lens design, toric multifocal, for the Biofinity (comfilcon A) Soft (hydrophilic) Extended Wear Contact Lenses.