- Device
- Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S109
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2020-08-11
- Decision code
- OK30
- Date received
- 2020-07-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacture of Biofinity XR Toric lenses on Biofinity Line 20 at the CooperVision Manufacturing Ltd. facility in Hamble, United Kingdom.