- Device
- comflicon A Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S202
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2026-06-16
- Decision code
- OK30
- Date received
- 2026-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- installation of a new gas chromatography (GC) instrument, and associated software, at the CooperVision, Inc. facility located in Hamble, United Kingdom