- Device
- Biofinity (comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S094
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2019-06-10
- Decision code
- OK30
- Date received
- 2019-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of manufacturing equipment at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.