- Device
- Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S116
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2020-09-21
- Decision code
- OK30
- Date received
- 2020-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an additional MTO (Made To Order) collation and packaging machine for the Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) soft (hydrophilic) contact lenses for extended wear at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom