- Device
- Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S115
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2020-09-16
- Decision code
- OK30
- Date received
- 2020-08-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new sterilizer installed at the CooperVision Manufacturing facility in Juana Diaz, Puerto Rico.