PMA P080011S138
- Device
- Biofinity Energys
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S138
- Product code
- LPM
- Decision date
- 2022-02-16
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Manufacture of Biofinity Energys on Biofinity Line 6 at the CooperVision Manufacturing, Ltd. facility in Hamble, UK.
Current openFDA PMA Record#
- Device
- Biofinity Energys
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S138
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2022-02-16
- Decision code
- OK30
- Date received
- 2022-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacture of Biofinity Energys on Biofinity Line 6 at the CooperVision Manufacturing, Ltd. facility in Hamble, UK.