- Device
- ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
- Applicant
- The Cooper Companies
- PMA number
- P890023
- Supplement
- S035
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2019-03-08
- Decision code
- APPR
- Date received
- 2018-08-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for new packaging and labeling site to CooperVision Manufacturing, Ltd, Southampton, United Kingdom.