- Device
- Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S096
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2019-09-05
- Decision code
- OK30
- Date received
- 2019-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of six packaging/labeling lines to the new packaging and labeling facility in Mountpark, Southampton, United Kingdom.