- Device
- Biofinity Sphere, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S145
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2022-05-03
- Decision code
- OK30
- Date received
- 2022-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an LED UV curing oven at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.