PMA P080011S148

Device: Biofinity XR Toric, Biofinity Toric Multifocal
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S148
Product code: LPM
Decision date: 2022-08-18
Generic name: Lenses, soft contact, extended wear
Approval order statement: Addition of Biofinity XR Toric and Biofinity Toric Multifocal N-Type lenses on the Biofinity Made-to-Order (MTO) manufacturing Line 3 at the CooperVision, Inc. facility in Scottsville, NY. Biofinity.

Current openFDA PMA Record#

Device: Biofinity XR Toric, Biofinity Toric Multifocal
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S148
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-08-18
Decision code: OK30
Date received: 2022-07-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of Biofinity XR Toric and Biofinity Toric Multifocal N-Type lenses on the Biofinity Made-to-Order (MTO) manufacturing Line 3 at the CooperVision, Inc. facility in Scottsville, NY. Biofinity.