PMA P080011S099
- Device
- Biofinity Toric
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S099
- Product code
- LPM
- Decision date
- 2019-10-09
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Manufacture of the Biofinity Toric (comfilcon A) Soft (hydrophilic) Contact Lens on Biofinity Line 4 at the facility in Hamble, United Kingdom.
Current openFDA PMA Record#
- Device
- Biofinity Toric
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S099
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2019-10-09
- Decision code
- OK30
- Date received
- 2019-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacture of the Biofinity Toric (comfilcon A) Soft (hydrophilic) Contact Lens on Biofinity Line 4 at the facility in Hamble, United Kingdom.