- Device
- Biofinity Sphere and Biofinity XR Sphere ; Biofinity Toric and Biofinity XR Toric ; Biofinity Multifocal ; Biofinity Ene
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S059
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2017-06-09
- Decision code
- OK30
- Date received
- 2017-05-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the denatured alcohol used in the extraction process for comfilcon A soft contact lenses.