PMA P080011S139

Device: Biofinity Toric Multifocal
Applicant: CooperVision, Inc.
Product code: LPM
Decision date: 2022-06-09
Generic name: Lenses, soft contact, extended wear
Approval order statement: Aapproval for the addition of the CooperVision, Inc. facility located at 711 North Road, Scottsville, New York 14546 as a manufacturing site for Biofinity Torie Multi focal.

Current openFDA PMA Record#

Device: Biofinity Toric Multifocal
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S139
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-06-09
Decision code: APPR
Date received: 2022-02-25
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Aapproval for the addition of the CooperVision, Inc. facility located at 711 North Road, Scottsville, New York 14546 as a manufacturing site for Biofinity Torie Multi focal.