- Device
- Biofinity XR Toric; Biofinity Toric Multifocal
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S134
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2021-11-19
- Decision code
- OK30
- Date received
- 2021-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the measurement of the junction thickness from the Biofinity MTO (Made To Order) Manufacturing Process at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.